U.S. patent application number 17/194113 was filed with the patent office on 2022-03-17 for delivery systems for cardiac valve devices, and associated methods of operation.
The applicant listed for this patent is Half Moon Medical, Inc.. Invention is credited to Jean-Pierre Dueri, Jose Gonzalez, Andrew Johnston, Gaurav Krishnamurthy, Jeffrey Martin, Matthew McLean, Robert O'Grady, Cassandra Orth, Douglas Sutton, Erik Thai, Neil Zimmerman.
Application Number | 20220079753 17/194113 |
Document ID | / |
Family ID | 1000005813190 |
Filed Date | 2022-03-17 |
United States Patent
Application |
20220079753 |
Kind Code |
A1 |
Zimmerman; Neil ; et
al. |
March 17, 2022 |
DELIVERY SYSTEMS FOR CARDIAC VALVE DEVICES, AND ASSOCIATED METHODS
OF OPERATION
Abstract
Delivery systems for implanting cardiac valve repair devices are
disclosed herein. In some embodiments, a delivery system includes a
delivery catheter, a hub shaft extending through the delivery
catheter, and a core shaft extending through the hub shaft. The
delivery catheter is configured to hold a valve repair device in a
compressed configuration. The hub shaft includes a hub configured
to releasably engage a first portion of the valve repair device,
and the core shaft includes a plug configured to releasably engage
a second portion of the valve repair device. When the valve repair
device is unsheathed from the delivery catheter, the hub shaft and
the core shaft are independently movable to axially
elongate/compress the valve repair device. When the valve repair
device is properly positioned, the hub can be actuated to release
the first portion of the valve repair device, and the plug can be
actuated to release the second portion of the valve repair
device.
Inventors: |
Zimmerman; Neil; (Menlo
Park, CA) ; Martin; Jeffrey; (San Lorenzo, CA)
; Dueri; Jean-Pierre; (Palo Alto, CA) ; Thai;
Erik; (San Jose, CA) ; Johnston; Andrew;
(Redwood City, CA) ; Sutton; Douglas; (Menlo Park,
CA) ; Orth; Cassandra; (Santa Clara, CA) ;
O'Grady; Robert; (San Francisco, CA) ; Gonzalez;
Jose; (Fremont, CA) ; McLean; Matthew; (San
Francisco, CA) ; Krishnamurthy; Gaurav; (Mountain
View, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Half Moon Medical, Inc. |
Menlo Park |
CA |
US |
|
|
Family ID: |
1000005813190 |
Appl. No.: |
17/194113 |
Filed: |
March 5, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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17024667 |
Sep 17, 2020 |
|
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17194113 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/2436 20130101;
A61F 2/2427 20130101; A61F 2210/0014 20130101; A61F 2/9517
20200501; A61F 2002/9505 20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24; A61F 2/95 20060101 A61F002/95 |
Claims
1. A method of implanting a medical device at a cardiac valve, the
method including: advancing the medical device to a target position
extending across the cardiac valve such that (a) a first end
portion of the medical device is positioned at a first side of the
cardiac valve upstream of a native valve anulus of the cardiac
valve and (b) a second end portion of the medical device is
positioned at a second side of the cardiac valve proximate to
native valve leaflets of the cardiac valve, wherein advancing the
medical device to the target position includes advancing the
medical device while the first end portion of the medical device is
coupled to a first shaft and the second end portion of the medical
device is coupled to a second shaft; releasing a first side of the
first end portion of the medical device from the first shaft; after
releasing the first side of the first end portion of the medical
device, releasing a second side of the first end portion of the
medical device from the first shaft; and releasing the second end
portion of the medical device from the second shaft.
2. The method of claim 1 wherein releasing the first side of the
first end portion of the medical device includes actuating a handle
operably coupled to a proximal end portion of the first shaft to
drive a hub assembly coupled to a distal end portion of the first
shaft to release a plurality of first connectors at the first side
of the first end portion of the medical device.
3. The method of claim 2 wherein releasing the second side of the
first end portion of the medical device includes further actuating
the handle to drive the hub assembly to release a plurality of
second connectors at the second side of the first end portion of
the medical device.
4. The method of claim 1 wherein the first end portion of the
medical device is coupled to the first shaft via a hub assembly,
wherein the hub assembly includes an inner hub component that is
movable relative to an outer hub component between a first
position, a second position, and a third position, and wherein--
advancing the medical device to the target position includes
advancing the medical device while the inner hub component is in
the first position, releasing the first side of the first end
portion of the medical device includes moving the inner hub
component from the first position to the second position, and
releasing the second side of the first end portion of the medical
device includes moving the inner hub component from the second
position to the third position.
5. The method of claim 1 wherein the first end portion of the
medical device is coupled to the first shaft via a hub assembly,
wherein the hub assembly includes an inner hub component that is
translatable relative to an outer hub component, and wherein--
advancing the medical device to the target position includes
advancing the medical device while the inner hub component is in a
first position relative to the outer hub component, releasing the
first side of the first end portion of the medical device includes
translating the inner hub component to a second position relative
to the outer hub component, and releasing the second side of the
first end portion of the medical device includes translating the
inner hub component to a third position relative to the outer hub
component.
6. The method of claim 1 wherein the first end portion of the
medical device is coupled to the first shaft via a hub assembly,
wherein the hub assembly includes an inner hub component that is
rotatable relative to an outer hub component, and wherein--
advancing the medical device to the target position includes
advancing the medical device while the inner hub component is in a
first position relative to the outer hub component, releasing the
first side of the first end portion of the medical device includes
rotating the inner hub component to a second position relative to
the outer hub component, and releasing the second side of the first
end portion of the medical device includes rotating the inner hub
component to a third position relative to the outer hub
component.
7. The method of claim 1 wherein the first end portion of the
medical device includes a plurality of connectors coupled to the
first shaft via a hub assembly, and wherein-- releasing the first
side of the first end portion of the medical device includes
sequentially releasing individual first ones of the connectors, and
releasing the second side of the first end portion of the medical
device includes sequentially releasing individual second ones of
the connectors.
8. The method of claim 1 wherein the first end portion of the
medical device includes a plurality of connectors coupled to the
first shaft via a hub assembly, and wherein-- releasing the first
side of the first end portion of the medical device includes
simultaneously releasing multiple first ones of the connectors, and
releasing the second side of the first end portion of the medical
device includes simultaneously releasing multiple second ones of
the connectors.
9. The method of claim 1 wherein the cardiac valve is a mitral
valve, and wherein the method further comprises capturing a portion
of one or more of the native leaflets of the mitral valve with the
medical device.
10. The method of claim 1 wherein the method includes releasing the
second end portion of the medical device before releasing the first
end portion of the medical device.
11. The method of claim 1 wherein the medical device includes an
atrial-fixation member and a coaptation member extending from the
atrial-fixation member, wherein the first end portion is of the
atrial-fixation member, wherein the second end portion is of the
coaptation member, and wherein-- releasing the first side of the
first end portion of the medical device includes releasing a
posterior side of the atrial-fixation member that is positioned
above the coaptation member; and releasing the second side of the
first end portion of the medical device includes releasing an
anterior side of the atrial-fixation member opposite the posterior
side.
12. A method of implanting a medical device at a cardiac valve of a
heart, the method including: advancing the medical device at least
partially into a chamber of the heart, wherein advancing the
medical device to the chamber includes advancing the medical device
while a first end portion of the medical device is coupled to a
first shaft and a second end portion of the medical device is
coupled to a second shaft; longitudinally compressing the medical
device by moving one or both of the first shaft and the second
shaft relative to one another; advancing the medical device to a
target position extending across the cardiac valve such that (a)
the first end portion of the medical device is positioned at a
first side of the cardiac valve upstream of a native valve anulus
of the cardiac valve and (b) the second end portion of the medical
device is positioned at a second side of the cardiac valve
proximate to native valve leaflets of the cardiac valve; releasing
the first end portion of the medical device from the first shaft;
and releasing the second end portion of the medical device from the
second shaft.
13. The method of claim 12 wherein the cardiac valve is a mitral
valve and the chamber is a left atrium, and wherein longitudinally
compressing the medical device includes longitudinally compressing
the medical device in the left atrium above the mitral valve.
14. The method of claim 13 wherein the method further comprises
steering the medical device toward the mitral valve after
longitudinally compressing the medical device.
15. A method of implanting a valve repair device at a cardiac
valve, the method comprising: endovascularly delivering a distal
portion of a delivery catheter to a chamber of a heart; unsheathing
at least a portion of the valve repair device from the delivery
catheter while in the chamber of the heart; longitudinally
compressing the valve repair device by moving one or both of (a) a
hub shaft secured to a first end portion of the valve repair device
and (b) a core shaft secured to a second end portion of the valve
repair device relative to one another; advancing the valve repair
device to a target position extending across the cardiac valve such
that the first end portion is positioned at a first side of the
cardiac valve upstream of a native valve anulus of the cardiac
valve and the second end portion is positioned at a second side of
the cardiac valve proximate to native valve leaflets of the cardiac
valve; releasing the second end portion of the valve repair device
from the core shaft; releasing a first side of the first end
portion of the valve repair device from the hub shaft; and after
releasing the first side of the first end portion of the valve
repair device, releasing a second side of the first end portion of
the valve repair device from the hub shaft.
16. The method of claim 15 wherein releasing the first side of the
first end portion of the valve repair device includes actuating a
handle operably coupled to a proximal end portion of the hub shaft
to drive a hub assembly coupled to a distal end portion of the hub
shaft to release a plurality of first connectors at the first side
of the first end portion of the valve repair device, and wherein
releasing the second side of the first end portion of the valve
repair device includes further actuating the handle to drive the
hub assembly to release a plurality of second connectors at the
second side of the first end portion of the valve repair
device.
17. The method of claim 15 wherein the cardiac valve is a mitral
valve and the chamber is a left atrium, wherein longitudinally
compressing the valve repair device includes longitudinally
compressing the valve repair device in a left atrium above the
mitral valve, and wherein the method further comprises capturing a
portion of one or more of the native leaflets of the mitral valve
with the valve repair device.
18. The method of claim 15 wherein the valve repair device includes
an atrial-fixation member and a coaptation member extending from
the atrial-fixation member, wherein the first end portion is of the
atrial-fixation member, wherein the second end portion is of the
coaptation member, and wherein-- releasing the first side of the
first end portion of the valve repair device includes releasing a
posterior side of the atrial-fixation member that is positioned
above the coaptation member; and releasing the second side of the
first end portion of the valve repair device includes releasing an
anterior side of the atrial-fixation member opposite the posterior
side.
19. The method of claim 15 wherein releasing the second end portion
of the valve repair device from the core shaft includes actuating a
handle operably coupled to the core shaft to drive the core shaft
to disengage a delivery attachment member fixedly attached to the
second end portion of the valve repair device.
20. The method of claim 19 wherein the delivery attachment member
is a nut, and wherein actuating the handle to drive the core shaft
to disengage the nut includes rotating a threaded member of the
core shaft to disengage the nut.
Description
CROSS-REFERENCE TO RELATED APPLICATION(S)
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 17/024,667, filed Sep. 17, 2020, and titled
"DELIVERY SYSTEMS FOR CARDIAC VALVE DEVICES, AND ASSOCIATED METHODS
OF OPERATION," which is incorporated herein by reference in its
entirety.
TECHNICAL FIELD
[0002] The present technology generally relates to delivery systems
for implanting cardiac valve devices via a minimally invasive
procedure, such as an endovascular approach.
BACKGROUND
[0003] Proper functioning of the mitral valve can be affected by
mitral valve regurgitation, mitral valve prolapse, and/or mitral
valve stenosis. Mitral valve regurgitation can occur when the
leaflets of the mitral valve fail to coapt into apposition at peak
contraction pressures such that blood leaks from the left ventricle
into the left atrium. Several structural factors may affect the
proper closure of the mitral valve leaflets. For example, an
enlarged mitral annulus caused by dilation of heart muscle may
prevent proper coaptation of the leaflets during systole. Other
conditions involve a stretch or tear in the chordae tendineae--the
tendons connecting the papillary muscles to the inferior side of
the mitral valve leaflets--which may also affect proper closure of
the mitral annulus. A ruptured chordae tendineae, for example, may
cause a valve leaflet to prolapse into the left atrium due to
inadequate tension on the leaflet. Abnormal backflow can also occur
when the papillary muscles are compromised (e.g., due to ischemia)
such that the affected papillary muscles do not contract
sufficiently to effect proper closure during systole.
[0004] Mitral valve prolapse can occur when the mitral leaflets
abnormally bulge up in to the left atrium, which can also lead to
mitral valve regurgitation. Normal functioning of the mitral valve
may also be affected by mitral valve stenosis, or a narrowing of
the mitral valve orifice, which impedes of filling of the left
ventricle during diastole.
[0005] Mitral valve regurgitation is often treated using diuretics
and/or vasodilators to reduce the amount of blood flowing back into
the left atrium. Other treatment methods, such as surgical
approaches (open and intravascular), have also been used to either
repair or replace the native mitral valve. For example, cinching or
resecting portions of the dilated annulus are typical repair
approaches. Cinching of the annulus has been accomplished by
implanting annular or peri-annular rings which are generally
secured to the annulus or surrounding tissue. Other repair
procedures have also involved suturing or clipping of the valve
leaflets into partial apposition with one another. Alternatively,
more invasive procedures replace the entire valve with mechanical
valves or biological tissue. These invasive procedures are
conventionally done through large open thoracotomies and are thus
very painful, have significant morbidity, and require long recovery
periods.
[0006] However, with many repair and replacement procedures, the
durability of the devices or improper sizing of annuloplasty rings
or replacement valves may cause complications. Moreover, many of
the repair procedures depend upon the skill of the cardiac surgeon
since poorly or inaccurately placed sutures may affect the success
of procedures.
[0007] Compared to other cardiac valves, the mitral valve presents
unique challenges because portions of the mitral valve annulus have
limited radial support from surrounding tissue and the mitral valve
has an irregular, unpredictable shape. For example, the anterior
wall of the mitral valve is bound by only a thin wall separating
the mitral valve annulus from the inferior portion of the aortic
outflow tract. As a result, significant radial forces on the mitral
valve annulus are not acceptable as they could lead to collapse of
the inferior portion of the aortic tract with potentially fatal
consequences. Another challenge of the mitral valve anatomy is that
the maze of chordae tendineae in the left ventricle makes
navigating and positioning a deployment catheter much more
difficult compared to other heart valves. Given the difficulties
associated with current procedures, there remains the need for
simple, effective, and less invasive devices and methods for
treating dysfunctional heart valves. Additionally, since it is also
difficult to deliver devices to the mitral valve, there also
remains the need for effective and less invasive delivery systems
to deliver the implantable cardiac devices to the mitral valve.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] Many aspects of the present disclosure can be better
understood with reference to the following drawings. The components
in the drawings are not necessarily to scale. Instead, emphasis is
placed on clearly illustrating the principles of the present
disclosure.
[0009] FIG. 1 is a diagram of a mitral valve that may be accessed
by a delivery system in accordance with embodiments of the present
technology.
[0010] FIGS. 2A and 2B are a top view and a side view,
respectively, of an implantable device that may be delivered to a
heart of a subject (e.g., a patient) using a delivery system in
accordance with embodiments of the present technology.
[0011] FIG. 3 is a perspective side view of a delivery system
configured in accordance with embodiments of the present
technology.
[0012] FIG. 4 is an enlarged isometric view of a distal portion of
the delivery system of FIG. 3 and the implantable device of FIGS.
2A and 2B in a partially-deployed position in accordance with
embodiments of the present technology.
[0013] FIGS. 5A-5C are enlarged side views of a hub attachment
mechanism of the delivery system of FIG. 3 in a first position, a
second position, and a third position, respectively, in accordance
with embodiments of the present technology.
[0014] FIGS. 5D-5F are cross-sectional side views of the hub
attachment mechanism of FIGS. 5A-5C in the first position, the
second position, and the third position, respectively, in
accordance with embodiments of the present technology.
[0015] FIGS. 6A-6C are an isometric view, a partial cross-sectional
proximally-facing isometric view, and a partially cross-sectional
distally-facing isometric view, respectively, of a hub shaft handle
of the delivery system of FIG. 3 in accordance with embodiments of
the present technology.
[0016] FIGS. 7A and 7B are an isometric side view and an enlarged
partial cross-sectional side view, respectively, of a distal plug
on a core shaft of the delivery system of FIG. 3 in accordance with
embodiments of the present technology.
[0017] FIGS. 8A-8D are a distally-facing isometric view, a
partially transparent side view, a partially transparent enlarged
top view, and a partially transparent proximally-facing isometric
view, respectively, of a core shaft handle of the delivery system
of FIG. 3 in accordance with embodiments of the present
technology.
[0018] FIGS. 8E-8H are a partially transparent side view, a
proximally-facing front view, a distally-facing isometric view, and
another distally-facing isometric view, respectively, of a clip
mount assembly and a cinch mount assembly of the core shaft handle
of FIGS. 8A-8D configured in accordance with embodiments of the
present technology.
[0019] FIG. 9 is a flow diagram of a process or method for
operating a delivery system to place the implantable device within
a patient in accordance with embodiments of the present
technology.
[0020] FIGS. 10A-10I are side views illustrating the implantable
device and a distal portion of the delivery system during various
stages of the method of FIG. 9 in accordance with embodiments of
the present technology.
[0021] FIG. 11 is a flow diagram illustrating a process or method
for releasing an implantable device from a delivery system in
accordance with embodiments of the present technology.
[0022] FIGS. 12A-12C are side views illustrating the implantable
device and a distal portion of the delivery system during various
stages of the method of FIG. 11 in accordance with embodiments of
the present technology.
[0023] FIG. 13A is a side view of a distal portion of a delivery
catheter of FIG. 3 configured in accordance with embodiments of the
present technology.
[0024] FIG. 13B is an enlarged cross-sectional view of a portion of
the delivery catheter of FIG. 3 taken along the line 13B-13B in
FIG. 13A.
[0025] FIGS. 14A-14D are a distally-facing isometric view, a
partially transparent side view, a partially transparent enlarged
top view, and a partially transparent proximally-facing isometric
view, respectively, of a core shaft handle configured in accordance
with additional embodiments of the present technology.
[0026] FIG. 15 is an enlarged side view of a hub assembly
configured in accordance with additional embodiments of the present
technology.
[0027] FIGS. 16A and 16B are an enlarged side view and a front
isometric view, respectively, of a hub assembly configured in
accordance with additional embodiments of the present
technology.
DETAILED DESCRIPTION
[0028] Aspects of the present disclosure are directed generally to
delivery systems for implanting a medical device, such as a valve
repair device or a prosthetic heart valve, in a heart of a subject
(e.g., a human patient). In several of the embodiments described
below, for example, a delivery system includes a delivery catheter
that holds an implantable medical device in a compressed
configuration, a hub shaft extending through the delivery catheter,
and a core shaft extending through the hub shaft. The hub shaft
includes a hub that releasably engages a first portion of the
medical device, and the core shaft includes a plug that releasably
engages a second portion of the medical device. When the medical
device is unsheathed from the delivery catheter, the hub shaft and
the core shaft are independently movable (e.g., translatable)
relative to one another to axially elongate or axially compress the
medical device. When the medical device is properly positioned in
the heart, the hub can be actuated to release the first portion of
the medical device, and the plug can be actuated to release the
second portion of the medical device.
[0029] In some embodiments, the medical device is configured to be
implanted at a mitral valve of the heart of the subject. In such
embodiments, the medical device can be implanted at the mitral
valve by at least partially unsheathing the medical device from the
delivery catheter in the left atrium above the mitral valve. The
medical device is then longitudinally compressed to improve ease of
steering by moving one or both of the hub shaft and the core shaft
relative to one another. Next, the guide catheter, the delivery
catheter, the hub shaft, and/or the core shaft can be used to steer
the medical device toward and across the mitral valve annulus such
that a portion of the medical device extends into the left
ventricle to capture a portion of one or more native leaflets of
the mitral valve and anchor the medical device in the sub-annular
space behind the leaflet. After determining that the medical device
is positioned and functioning properly, the hub and the plug can be
actuated to disengage the medical device, leaving the medical
device anchored to tissue surrounding the mitral valve.
[0030] Specific details of several embodiments of the present
technology are described herein with reference to FIGS. 1-12D. The
present technology, however, can be practiced without some of these
specific details. In some instances, well-known structures and
techniques often associated with catheter-based delivery systems,
prosthetic heart valves, etc., have not been shown in detail so as
not to obscure the present technology. The terminology used in the
description presented below is intended to be interpreted in its
broadest reasonable manner, even though it is being used in
conjunction with a detailed description of certain specific
embodiments of the disclosure. Certain terms can even be emphasized
below; however, any terminology intended to be interpreted in any
restricted manner will be overtly and specifically defined as such
in this Detailed Description section.
[0031] The accompanying Figures depict embodiments of the present
technology and are not intended to be limiting of its scope. The
sizes of various depicted elements are not necessarily drawn to
scale, and these various elements can be arbitrarily enlarged to
improve legibility. Component details can be abstracted in the
Figures to exclude details such as position of components and
certain precise connections between such components when such
details are unnecessary for a complete understanding of how to make
and use the present technology. Many of the details, dimensions,
angles, and other features shown in the Figures are merely
illustrative of particular embodiments of the disclosure.
Accordingly, other embodiments can have other details, dimensions,
angles, and features without departing from the spirit or scope of
the present technology.
[0032] With regard to the terms "distal" and "proximal" within this
description, unless otherwise specified, the terms can reference a
relative position of the portions of a catheter subsystem with
reference to an operator and/or a location in the vasculature.
Also, as used herein, the designations "rearward," "forward,"
"upward," "downward," etc., are not meant to limit the referenced
component to use in a specific orientation. It will be appreciated
that such designations refer to the orientation of the referenced
component as illustrated in the Figures; the systems of the present
technology can be used in any orientation suitable to the user.
[0033] The headings provided herein are for convenience only and
should not be construed as limiting the subject matter
disclosed.
I. Selected Embodiments of Implantable Devices and Associated Valve
Anatomy
[0034] FIG. 1 is a diagram of a mitral valve that may be accessed
by a delivery system in accordance with embodiments of the present
technology. The anterior leaflet has a semi-circular shape and
attaches to approximately two-fifths of the annular circumference.
The motion of the anterior leaflet defines an important boundary
between the inflow (diastole) and outflow (systole) tracts of the
left ventricle. The posterior leaflet of the mitral valve has a
crescent shape and is attached to approximately three-fifths of the
annular circumference. The posterior leaflet typically has two
well-defined indentations which divide the leaflet into three
individual scallops identified as P1 (lateral scallop), P2 (middle
scallop), and P3 (medial scallop). The three corresponding segments
of the anterior leaflet are identified as A1 (lateral segment), A2
(middle segment), and A3 (medial segment). The leaflet indentations
aid in opening the posterior leaflet during diastole.
[0035] As shown in FIG. 1, the mitral valve has anterolateral and
posteromedial commissures which define a distinct area where the
anterior and posterior leaflets come together at their insertion
into the annulus. Sometimes the commissures exist as well-defined
leaflet segments, but often this area is a subtle structure that
can be identified using the following two anatomic landmarks: (a)
the axis of corresponding papillary muscles, and (b) the
commissural chordae, which have a specific fan-like configuration.
Several millimeters of valvular tissue separate the free edge of
the commissures from the annulus.
[0036] The mitral valve is an atrio-ventricular valve separating
the left atrium from the left ventricle. The mitral annulus
constitutes the anatomical junction between the left ventricle and
the left atrium. The fixed ends of the leaflets are attached to the
annulus. The anterior portion of the mitral annulus is attached to
the fibrous trigones and is generally more developed than the
posterior annulus. The right fibrous trigone is a dense junctional
area between the mitral valve, tricuspid valve, non-coronary cusp
of the aortic valve, and the membranous septum. The left fibrous
trigone is situated at the junction of both left fibrous borders of
the aortic valve and the mitral valve.
[0037] The mitral annulus is less well developed at the insertion
site of the posterior leaflet. This segment is not attached to any
fibrous structures, and the fibrous skeleton in this region is
discontinuous. This posterior portion of the annulus is prone to
increase its circumference when mitral regurgitation occurs in
association with left atrial or left ventricular dilation. The
mitral annulus is saddle-shaped, and during systole the commissural
areas move proximally--that is, towards the roof of the
atrium--while annular contraction also narrows the circumference.
Both processes aid in achieving leaflet coaptation, which may be
adversely affected by annular dilatation and calcification. The
mitral annulus is surrounded by several important anatomic
structures, including the aortic valve, the coronary sinus, and the
circumflex artery. As a result, implanted cardiac devices at the
mitral valve need to be positioned to accommodate the asymmetrical
anatomy of the mitral valve without impacting the surrounding
cardiac structures.
[0038] FIGS. 2A and 2B are a top view and a side view,
respectively, of an implantable device 200 that may be delivered to
a heart of a subject (e.g., a human patient) using a delivery
system in accordance with embodiments of the present technology.
Referring to FIGS. 2A and 2B together, in the illustrated
embodiment the implantable device 200 is a valve repair device
having an atrial-fixation member 202 (also referred to as an
"anchoring member" or a "brim") and a coaptation member 204 (also
referred to as a "baffle") extending from the atrial-fixation
member 202 in a downstream direction. The atrial-fixation member
202 is configured to anchor the implantable device 200 to cardiac
tissue proximate to a native mitral valve annulus and position the
coaptation member 204 at a desired location with respect to the
native valve anatomy of the heart. The coaptation member 204 is
configured to displace at least a portion of one or more native
leaflets of a cardiac valve and create a prosthetic coaptation
surface for at least a portion of one or more of the other native
leaflets of the cardiac valve. For example, when the implantable
device 200 is deployed across the mitral valve annulus, the
coaptation member 204 may extend in front of a central portion of
the posterior leaflet (i.e., P2 of the posterior leaflet), pushing
the posterior leaflet back toward the ventricular wall, such that
the coaptation member 204 is positioned to coapt with the anterior
leaflet during systole. The implantable device 200 is configured
relative to a flow axis VA (FIG. 2B) in the direction of blood flow
from the atrium to the ventricle and a transverse axis HA (FIG. 2A)
at an angle (e.g., orthogonal) to the flow axis VA. The implantable
device 200 has a posterior side portion P (e.g., a first side
portion), an anterior side portion A (e.g., a second side portion),
a superior end portion S (e.g., a first end portion), and an
inferior end portion I (e.g., a second end portion).
[0039] In some embodiments, the implantable device 200 can include
some features generally similar or identical to the implantable
devices described in (i) U.S. patent application Ser. No.
16/044,447, titled "PROSTHETIC LEAFLET DEVICE," and filed Jul. 24,
2018, (ii) International Patent Application No. PCT/US2018/061126,
titled "LEAFLET EXTENSION FOR CARDIAC VALVE LEAFLET," and filed
Nov. 14, 2018, (iii) U.S. patent application Ser. No. 16/745,246,
titled "IMPLANTABLE COAPTATION ASSIST DEVICES WITH SENSORS AND
ASSOCIATED SYSTEMS AND METHODS," and filed Jan. 16, 2020, and/or
(iv) U.S. patent application Ser. No. 16/817,464, titled "CARDIAC
VALVE REPAIR DEVICES WITH ANNULOPLASTY FEATURES AND ASSOCIATED
SYSTEMS AND METHODS," and filed Mar. 12, 2020, each of which are
incorporated herein by reference in their entirety. Any of several
prosthetic valve repair or replacement devices could similarly be
used with delivery systems in accordance with the present
technology, including complete mitral valve replacement devices.
And, in addition to mitral valve devices, other valve repair or
replacement devices could be delivered to the tricuspid, aortic,
and pulmonic valves using delivery systems in accordance with the
present invention.
[0040] The atrial-fixation member 202 can be formed of a mesh, such
as a braid or laser-cut stent-like structure, including a plurality
of interconnected wires or struts 206 which together define a
plurality of openings or cells 208 (e.g., diamond-shaped openings)
arranged in one or more rows. The struts 206 can be configured to
self-expand from a collapsed delivery state (not shown) to an
expanded deployed state shown in FIGS. 2A and 2B. The struts 206
can be formed of any biocompatible material such as, for example,
stainless steel, nickel-titanium alloys (e.g., nitinol), and/or
other suitable stent materials. The atrial-fixation member 202 can
have a generally circular, oval, or D-like shape in the deployed
state and define an open central lumen 211 (also referred to as an
"opening") that allows blood to pass therethrough along the flow
axis VA. When the implantable device 200 is configured to repair a
native mitral valve, the atrial-fixation member 202 can be shaped
to conform to the walls of the left atrium just above the mitral
annulus to secure the implantable device 200 to the supra-annular
tissue. After a period of time post-implantation (e.g., 3 days, 2
weeks, 1 month, 2 months, the atrial-fixation member 202 or
portions thereof become covered by a layer of tissue, and this
tissue ingrowth adheres the implantable device 200 permanently to
the atrial wall. In some embodiments, the atrial-fixation member
202 has a semi-circular or other shape that does not extend fully
around the circumference of the native valve. In some embodiments,
the atrial-fixation member 202 may also or alternatively include
one or more portions that press against sub-annular tissue to
provide sub-annular device fixation.
[0041] In some embodiments, the atrial-fixation member 202 can
include connectors 205 that are configured (e.g., sized, shaped,
and/or positioned) to engage with a mating feature on the delivery
system, as described in detail below with reference to FIGS. 5A-5F.
As shown in FIG. 2B, for example, the connectors 205 may be extend
from the struts 206 such that the connectors 205 are positioned
near or at the superior end portion S of the implantable device
200. In some embodiments, the atrial-fixation member 202 includes
one or more eyelets 207 configured to receive one or more tendons
(e.g., a cinch tendon 439 illustrated in FIG. 4) that aids in
packing (e.g., compressing), delivering, orienting, and/or
retrieving the implantable device 200. For example, the tendons can
help facilitate cinching (e.g., radially compressing) of the
atrial-fixation member 202. The eyelets 207 can be metal portions
of the atrial-fixation member 202, or can be separate
filaments/wires forming loops and attached to the atrial-fixation
member 202.
[0042] As shown in FIGS. 2A and 2B, the coaptation structure 204
extends away from a downstream end portion of the atrial-fixation
member 202 along the flow axis VA and at least a portion of the
coaptation member 204 extends radially inward from the
atrial-fixation member 202 into the central lumen 211 to
approximate a closed position of a native leaflet. The coaptation
member 204 can be substantially stationary (e.g., little to no
movement) during cardiac cycles such that the position of the
coaptation member 204 relative to the atrial-fixation member 202 is
at least substantially fixed in the deployed state. Thus, unlike
native leaflets that move back and forth to open and close the
native valve, the coaptation member 204 remains stationary during
diastole and systole.
[0043] The coaptation member 204 can have an anterior portion 212
(FIG. 2B) with a smooth, atraumatic surface for coapting with at
least a portion of one or more native leaflets and a posterior
portion 214 (FIG. 2B) configured to displace and, optionally,
engage at least a portion of another native leaflet. The coaptation
member 204 can be made from a plurality of struts that form a
basket-like or frame-like structure (e.g., a mesh structure, a
laser cut stent frame) with an at least partially hollow interior
and a covering (e.g., a fabric) extending over at least a portion
of the struts to provide a smooth suitable surface for coaptation
at the anterior portion 212. The covering may also extend over the
struts along the posterior portion 214 and between the anterior and
posterior portions 212, 214 in a manner that forms lateral
sidewalls. The baffle 204 or portions thereof can be integral with
the atrial-fixation member 202 such that, for example, the
coaptation member 204 is manufactured from the same frame including
the struts 206. In other embodiments, the baffle 204 can be a
separate structure that is connected to a portion of the
atrial-fixation member 202 during manufacturing. In some
embodiments, the baffle 204 can include a biocompatible foam which
is attached to the structure of the baffle 204 and/or to the
atrial-fixation member 202.
[0044] In the illustrated embodiment, the baffle 204 further
includes a normally-closed clip 209 (obscured in FIG. 2A) depending
from its posterior surface which can be opened to extend behind the
native leaflet the coaptation member 204 displaces. The clip 209
may grasp the native leaflet and/or engage sub-annular cardiac
tissue for sub-annular stabilization of the implantable device 200.
In some embodiments, for example, the clip 209 reaches under the
central portion (i.e., P2) of the posterior leaflet up to the
sub-annular space. A tendon (made of suture or nitinol wire) can
actuate the clip 209 by way of a lever attached to the clip 209.
The lever may be a nitinol wire or laser cut nitinol or Co--Cr
sheet.
[0045] As shown in FIG. 2A, the baffle 204 can further include a
delivery attachment member 203 (shown in broken lines) positioned
within the hollow interior of the baffle 204. The delivery
attachment member 203 can be a threaded nut or other type of
connector configured to mate with a corresponding portion (e.g., a
screw) of the delivery system, as described in greater detail below
with reference to FIGS. 4, 7A, and 7B. In some embodiments, the
delivery attachment member 203 is accessible via a flap or opening
201 (FIG. 2A) formed in the baffle 204 (e.g., in portion of the
baffle facing the superior end portion S of the implantable device
200).
[0046] The implantable device 200 may be inserted via a femoral
vein sheath to traverse the inferior vena cava to the right atrium.
The implantable device 200 is then inserted into the left atrium
via a puncture of the interatrial septum. In several applications,
the implantable device 200 is delivered to a target location within
the mitral valve to function properly. This means appropriate
positioning along the flow axis VA, correct radial positioning
relative to the central axis of the valve, correct rotational
orientation to specific landmarks such as the middle (P2) portion
of the native posterior leaflet, and correct angular positioning
relative to the flow axis and the transverse axis. In some
embodiments, the implantable device 200 may also be repositioned
during the delivery process to, for example, correct for
misalignment or inappropriate positioning. During deployment and
release of the implantable device 200, the delivery system can
retain the implantable device 200 in a stationary position at the
desired location and in the desired orientation relative to the
native valve. Furthermore, the delivery system may be configured to
allow the implantable device 200 to be re-sheathed, repositioned,
and/or removed before being released from the delivery system.
Delivery systems of the present technology can achieve all the
above-mentioned advantages in a user-friendly system. Additionally,
several embodiments of delivery systems in accordance with the
present technology have a small overall diameter, such as
approximately 15 to 30 French.
II. Selected Embodiments of Delivery Systems
[0047] FIG. 3 is a perspective side view of a delivery system 310
configured in accordance with embodiments of the present
technology. The delivery system 310 can be used to deliver an
implantable device, such as the implantable valve repair device 200
of FIGS. 2A and 2B, to a heart of a subject (e.g., a human
patient). In the illustrated embodiment, the delivery system 310
includes four nested/coaxial catheter/shaft structures: (i) an
outer guide catheter 312, (ii) a delivery catheter 314 (also
referred to as a "sleeve") configured to extend at least partially
through the guide catheter 312, (iii) a hub shaft 316 configured to
extend at least partially through the delivery catheter 314, and
(iv) a core shaft 318 configured to extend at least partially
through the hub shaft 316 (collectively "catheters 312-318" or
"shafts 312-318"). The catheters 312-318 can be individually
manipulated and/or moved relative to one another to facilitate
deployment of the implantable device 200. More specifically, in the
illustrated embodiment (i) the guide catheter 312 is coupled to a
guide catheter handle 322, (ii) the delivery catheter 314 is
coupled to a delivery catheter handle 324, (iii) the hub shaft 316
is coupled to a hub shaft handle 326, and (iv) the core shaft 318
is coupled to a core shaft handle 328 (collectively "handles
322-328" or "handle assembly"). In some embodiments, the delivery
system 310 further includes a dilator assembly 319 configured to be
advanced/retracted through the guide catheter 312 prior to
introduction of the delivery catheter 314, the hub shaft 316,
and/or the core shaft 318.
[0048] In some embodiments, the handles 322-328 and/or portions of
the catheters 312-318 are coupled/mounted to a common handle
support assembly 320 (also referred to as a "rack assembly" or
"control rack") that facilitates relative movement between the
individual catheters 312-318, while maintaining the handles 322-328
in a stable, supported position and inhibiting unwanted movement
therebetween. The support assembly 320 can include a proximal fixed
portion 321 (e.g., a first stand), a distal fixed portion 323
(e.g., a second stand), and one or more tracks 325 extending at
least partially between the proximal and distal fixed portions
321,323. In the illustrated embodiment, the guide catheter handle
322 is removably mounted to the distal fixed portion 323.
[0049] As shown in FIG. 3, the support assembly 320 can further
include a plurality of mounts 327 (identified individually as first
through third mounts 327a-327c, respectively) slidably coupled to
one or more of the tracks 325. The first mount 327a is configured
to receive and secure the delivery catheter handle 324, and
includes a first actuation member 329a (e.g., a wheel, slider,
knob, button) for individually moving the first mount 327a--and the
delivery catheter handle 324 and the delivery catheter 314 coupled
thereto--linearly along the tracks 325 relative to the other ones
of the handles 322-328. The second mount 327b is positioned
proximal of the first mount 327a and is configured to receive and
secure the hub shaft handle 326. Similarly, the second mount 327b
includes a second actuation member 329b for individually moving the
second mount 327b and the hub shaft handle 326. Likewise, the third
mount 327c is positioned proximal of the second mount 327b, is
configured to receive and secure the core shaft handle 328, and
includes a third actuation member 329c for individually moving the
third mount 327c and the core shaft handle 328. In the illustrated
embodiment, the support assembly 320 further includes a linear
drive mechanism 330 (e.g., a screw drive, a rack and pinion)
configured to jointly advance/retract the delivery catheter handle
324, the hub shaft handle 326, and the core shaft handle 328
without moving the handles relative to one another. In some
embodiments, the linear drive mechanism 330 is coupled to only a
subset of the handles 322-328 and/or the system 310 can include
more than one linear drive mechanism to linearly advance one or
more of the handles 322-328.
[0050] The guide catheter 312 and the delivery catheter 314 can
each have varying stiffnesses along a length thereof and/or can be
steerable catheters that allow the catheters 312, 314 to deflect
along one or more axes. In some embodiments, for example, the guide
catheter handle 322 includes a guide actuation member 331 (e.g., a
wheel, lever, knob, slider) that is actuatable to deflect a distal
portion of the guide catheter 312. More specifically, the guide
actuation member 331 can be coupled to a pull wire that is attached
to a pull ring fixed at a distal portion of the guide catheter 312.
Similarly, the delivery catheter handle 324 can include a delivery
actuation member 333 that is actuatable to deflect a distal portion
of the delivery catheter 314. In some embodiments, the guide
catheter 312 has a diameter of less than about 30 French (e.g.,
about 29.5 French or less) and the delivery catheter 314 has a
diameter of about 26 French or less.
[0051] More specifically, FIG. 13A is a side view of a distal
portion of the delivery catheter 314 configured in accordance with
embodiments of the present technology. In the illustrated
embodiment, the delivery catheter 314 includes a distal terminus
370, a first region 372 (e.g., a distal region) adjacent the distal
terminus 370, and a second region 374 (e.g., a proximal region)
adjacent to and proximal of the first region 372. FIG. 13B is an
enlarged cross-sectional view of a portion of the delivery catheter
314 (e.g., a portion of a wall of the delivery catheter 314) taken
along the line 13B-13B in FIG. 13A. In the illustrated embodiment,
the delivery catheter 314 includes an outer jacket layer 380, an
inner liner layer 382, and one or more layers of braided and/or
coiled reinforcement material 384 between the inner liner and outer
jacket layers 382, 380 (collectively "layers 380-384"). The inner
liner and outer jacket layers 382, 380 can be formed of
polytetrafluoroethylene (PTFE), plastic, elastomer, thermoplastic
elastomer (TPE) (e.g., a TPE manufactured by Arkema S. A., of
Colombes, France, such as the TPEs manufactured under the trademark
"Pebax"), nylon, and/or other suitable materials, and the layers of
braided and/or coiled material 384 can be formed from metal wires
and/or stiffer polymers.
[0052] Referring to FIGS. 13A and 13B together, the delivery
catheter 314 can further include a pull wire 376 (obscured by the
outer jacket layer 380 in FIG. 13A and shown schematically)
extending through a lumen between some of the layers 380-384 and
having (i) a distal end or portion coupled to a pull ring 377
(obscured by the outer jacket layer 380 in FIG. 13A and shown
schematically) positioned in the first region 372 near the distal
terminus 370 and (ii) a proximal end or portion coupled to the
delivery actuation member 333 of the delivery catheter handle 324
(FIG. 3). Actuation of the delivery actuation member 333 can pull
the pull wire 376 to cause the first region 372 and/or the second
region 374 to deflect (e.g., in the direction indicated by arrow D
in FIG. 13B).
[0053] In some embodiments, the delivery catheter 314 can further
include a spine 378 (also referred to as an "elongate member")
extending at least partially through/along one or more of the
layers 380-384. In the illustrated embodiment, the spine 378
extends along the second region 374 but not the first region 372.
In some embodiments, the first region 372 can have a length of
between about 10-50 millimeters (e.g., about 20 millimeters), and
the second region 374 and the spine 378 can have a length of
between about 20-80 millimeters (e.g., about 50 millimeters). The
spine 378 can be formed of metal or other suitably rigid materials
and is positioned adjacent to (e.g., parallel to) the pull wire 376
along the second region 374. In some embodiments, the spine 378 is
a metal wire welded (e.g., tack-welded) to the coil reinforcement
wire 384 along the second region 374. In some embodiments, when the
pull wire 376 is pulled to deflect the delivery catheter 314, the
spine 378 inhibits or even prevents the second region 374 of the
delivery catheter 376 from flexing in the direction indicated by
the arrow D. That is, the spine 378 can inhibit the second region
374 from deflecting while still permitting the first region 372 to
deflect in the direction of arrow D. Accordingly, as shown in
phantom in FIG. 13A, an angle .theta. between the first and second
regions 372, 374 after actuation of the pull wire 376 can be
greater than the angle .theta. would be without the spine 378. At
the same time, the spine 378 can still permit the second region 374
to bend in directions other than the direction of arrow D, such as
along an axis O orthogonal to the direction of arrow D. In some
aspects of the present technology, this selective flexibility can
facilitate advancement of the delivery catheter 314 through the
guide catheter 312 (FIG. 3) and/or permit the guide catheter 312 to
bend the delivery catheter 314 along the axis O. That is, the spine
378 can provide the delivery catheter 314 with selective
flexibility--allowing the delivery catheter 314 to bend along the
axis O while remaining stiff and inhibiting bending in the
direction of arrow D when the pull wire 376 is pulled.
[0054] During a delivery procedure using the delivery system 310,
the distal portion of the delivery catheter 314 retains the
implantable device 200 in the compressed delivery state and, upon
reaching a target region (e.g., in the left atrium), begins to
deploy (e.g., unsheathe) the implantable device 200 by retracting
the delivery catheter 314 and/or advancing the implantable device
200 beyond the distal terminus of the delivery catheter 314. This
allows the implantable device 200 to partially expand toward the
deployed state, while still being releasably secured to a distal
portion of the hub shaft 316 and a distal portion of the core shaft
318. In FIG. 3, for example, the implantable device 200 is shown in
a partially-deployed position (also referred to as a
"partially-deployed state") in which the implantable device 200 (i)
has been advanced out of the distal portion of the delivery
catheter 314, but (ii) is still secured to the hub shaft 316 and
the core shaft 318 to allow for controlled movement (e.g., linear,
rotational) and further deployment of the partially-deployed
implantable device 200.
[0055] More specifically, FIG. 4 is an enlarged isometric view of a
distal portion of the delivery system 310 and the implantable
device 200 in the partially-deployed position in accordance with
embodiments of the present technology. In the illustrated
embodiment, the hub shaft 316 includes a distal hub assembly 436
(described in further detail below with reference to FIGS. 5A-5F)
that releasably engages a portion (e.g., the connectors 205 (FIG.
2)) of the implantable device 200. The core shaft 318 includes a
distal plug assembly 438 (also referred to as a "core plug" or
"plug,"; described in further detail below with reference to FIGS.
7A and 7B) extending through the opening 201 in the baffle 204 and
that is releasably coupled to the delivery attachment member 203.
Accordingly, relative linear translation between the hub shaft 316
and the core shaft 318 can elongate and/or shorten (e.g., axially,
longitudinally, etc.) the implantable device 200 and, more
particularly, the atrial-fixation member 202. In the illustrated
embodiment, the plug assembly 438 further includes a flexible tube
437 (e.g., a coiled tube) extending therefrom to route a cinch
tendon 439 (e.g., a suture) from the proximal portion of the
delivery system 310 (e.g., near or at the handles 322-328) to the
eyelets 207 of the atrial-fixation member 202.
[0056] Referring to FIGS. 3 and 4 together, in some embodiments one
or more of the handles 322-328 can be coupled together using means
that inhibit relative rotational motion of the handles 322-328. In
the illustrated embodiment, for example, the hub shaft handle 326
is slidably coupled to the core shaft handle 328 via a pair of
rails 332 (e.g., rigid members, such as rods) that inhibit or even
prevent the hub shaft handle 326 and the core shaft handle 328 from
rotating relative to one another. Thus, the hub shaft 316 and the
core shaft 318 extending from the corresponding hub shaft and core
shaft handles 326 and 328 can be rotationally fixed relative to
each other (or at least substantially so) during implant
procedures. Accordingly, the rails 332 can inhibit or even prevent
twisting of the implantable device 200, which has portions coupled
to both the hub shaft 316 and the core shaft 318, during an implant
procedure that could otherwise arise from rotation of the hub shaft
316 relative to the core shaft 318. In the illustrated embodiment,
the hub shaft handle 326 is coupled to the core shaft handle 328
via two rails, whereas in further embodiments the two handles 326,
328 may be coupled together with a single rail, more than two rails
(e.g., three, four, five, or more rails), and/or other coupling
mechanisms that maintain the rotational alignment of the handles
326, 328 and the catheters and shafts coupled thereto. In other
embodiments, the handles 326, 328 can be integrated into a single
handle including the various components and functionality described
in detail below with reference to FIGS. 8A-8H and/or 14A-14D. In
some embodiments, other handles or subsets of handles 322-328 are
coupled together in a similar manner to avoid relative motion
between the handles 322-328.
[0057] FIGS. 5A-5C are enlarged side views of the hub assembly 436
of FIG. 4 in a first position, a second position, and a third
position, respectively, in accordance with embodiments of the
present technology. FIGS. 5D-5F are side cross-sectional views of
the hub assembly 436 in the first position, the second position,
and the third position, respectively, in accordance with
embodiments of the present technology. Referring first to FIGS. 5A
and 5D together, the hub assembly 436 includes an inner hub
component 540 and an outer hub component 542 (also referred to as a
"capsule"). The outer hub component 542 is shown as partially
transparent in FIGS. 5A-5F for the sake of clarity. The inner hub
component 540 includes an outer surface 541, a proximal side or
edge 543a, and a distal side or edge 543b. In the illustrated
embodiment, the outer surface 541 of the inner hub component 540
includes a plurality/group of first recesses 544 and a
plurality/group of second recesses 546 that extend from the distal
edge 543b toward the proximal edge 543a. The first and second
recesses 544, 546 are configured (e.g., shaped, sized, and/or
positioned) to receive and secure corresponding ones of the
connectors 205 of the implantable device 200 (FIGS. 2A and 2B). In
some embodiments, the first and second recesses 544, 546 can have a
generally similar shape including (i) a first portion 545 having a
generally elongate (e.g., rectangular) shape for receiving a
portion of a corresponding one of the struts 206 (FIGS. 2A and 2B)
and (ii) a second portion 547 having a generally circular shape for
receiving a corresponding one of the connectors 205 (FIGS. 2A and
2B). In other embodiments, the first and second recesses 544, 546
can have other suitable shapes for receiving and securing the
connectors 205 and/or other features at the superior end portion S
of the implantable device 200.
[0058] In the illustrated embodiment, the first recesses 544 are
circumferentially spaced apart from the second recesses 546. That
is, the first recesses 544 are positioned along/in a first
circumferential portion of the outer surface 541, while the second
recesses 546 are positioned along a second circumferential portion
of the outer surface 541. In some embodiments, the first portions
545 of the second recesses 546 are shorter than the first portions
545 of the first recesses 544 (e.g., in a direction extending
between the proximal and distal edges 543a, b). Accordingly, the
second portions 547 of the second recesses 546 can be positioned
closer to the distal edge 543b than the second portions 547 of the
first recesses 544. In some embodiments, the first recesses 544 are
configured to receive corresponding ones of the connectors 205
positioned at the anterior side portion A of the implantable device
200 (FIGS. 2A and 2B), while the second recesses 546 are configured
to receive corresponding ones of the connectors 205 positioned at
the posterior side portion P of the implantable device 200. As
described in greater detail below with reference to FIGS. 5B, 5C,
5E, 5F and 11-12D, this arrangement can facilitate a two-stage
release of the implantable device 200 in which the connectors 205
positioned at the posterior side portion P of the implantable
device 200 are released from the hub assembly 436 before the
connectors 205 positioned at the anterior side portion A of the
implantable device 200. In some embodiments, the inner hub
component 540 can include recesses that are aligned for a
single-stage deployment, or recesses that are arranged around the
outer surface 541 to facilitate deployment in three or more
stages.
[0059] In the illustrated embodiment, the outer hub component 542
includes a distal opening 549 and, in the first position
illustrated in FIGS. 5A and 5D, each of the first and second
recesses 544, 546 are positioned proximal of the distal opening
549. Accordingly, in the first position, the connectors 205 of the
implantable device 200 are secured/restrained in the first and
second recesses 544, 546 by the outer hub component 542.
[0060] As best seen in FIG. 5D, the inner hub component 540
includes/defines a drive lumen 550 and a lock lumen 564 both
extending at least partially from the proximal edge 543a toward the
distal edge 543b. The drive lumen 550 includes a stepped stop
surface 551 such that the drive lumen 550 has a larger dimension
(e.g., diameter) distal of the stop surface 551. The drive lumen
550 further includes a threaded portion 553 proximal of the stop
surface 551. Likewise, the lock lumen 564 includes a stepped or
tapered stop surface 554 such that the lock lumen 564 has a larger
dimension distal of the stop surface 554.
[0061] The hub assembly 436 can further include a lead screw 555
extending at least partially through the drive lumen 550 and
operably coupling the inner hub component 540 to a drive shaft 552.
More specifically, the lead screw 555 can include a threaded outer
surface 556 configured to engage/mate with the threaded portion 553
of the drive lumen 550. In the illustrated embodiment, the lead
screw 555 includes a stop member 557 configured (e.g., sized and/or
shaped) to engage the stop surface 551 in the third position shown
in FIGS. 5C and 5F. The drive shaft 552 can be coupled to the lead
screw 555 via welding, adhesives, fasteners, and/or other suitable
types of connections, or the drive shaft 552 and the lead screw 555
can be manufactured from a single piece of wire or rod.
[0062] As shown in FIGS. 5D-5F, the hub assembly 436 can further
include a lock pin 558 extending at least partially through the
lock lumen 564 and operably coupling the inner hub component 540 to
the outer hub component 542. For example, the lock pin 558 can
include a flared portion 559 configured to engage a corresponding
stop surface 560 of the outer hub component 542 or another
component coupled to the outer hub component 542. The lock pin 558
further includes a stop member 561 configured to engage the stop
surface 554 of the lock lumen 564 in the second position shown in
FIGS. 5B and 5E. In the illustrated embodiment, the lock pin 558
defines a release lumen 563 configured to receive a release shaft
562. A dimension (e.g., diameter) of the release lumen 563 can be
slightly greater than a corresponding dimension of the release
shaft 562 such that an outer surface of the release shaft 562
engages an inner surface of the lock pin 558 when the release shaft
562 is positioned within the release lumen 563. In some
embodiments, (i) the release shaft 562 is formed from a rigid
material, such as a nickel-titanium alloy, that does not compress
easily while (ii) the flared portion 559 of the lock pin 558 is
biased radially inward and/or formed of a relatively compressible
material. Accordingly, when the release shaft 562 is positioned in
the release lumen 563, the release shaft 562 can bias/force the
flared portion 559 of the lock pin 558 radially outward such that
the flared portion 559 remains in engagement with the stop surface
560 of the outer hub component 542 even when the lock pin 558 is
urged distally. In other embodiments, the hub assembly 436 can
include other locking mechanisms for inhibiting movement of the
inner hub component 540.
[0063] The drive shaft 552 and the release shaft 562 extend from
the hub assembly 436, through the hub shaft 316 (FIG. 4), and to
the hub shaft handle 326. FIGS. 6A-6C are an isometric view, a
partially cross-sectional proximally-facing isometric view, and a
partially cross-sectional distally-facing isometric view,
respectively, of the hub shaft handle 326 in accordance with
embodiments of the present technology. In general, the hub shaft
handle 326 can be manipulated/actuated by a user to actuate the
drive shaft 552 and/or the release shaft 562 to drive movement of
the hub assembly 436 and release the connectors 205 of the
implantable device 200 (FIGS. 2A and 2B) during device
deployment.
[0064] Referring to FIGS. 6A-6C together, the hub shaft handle 326
includes a body component 670 coupled to a gear assembly 680. The
body component 670 is shown as cross-sectional in FIGS. 6B and 6C.
The body component 670 includes/defines a series of interconnected
lumens including a hub shaft lumen 671 and a valve lumen 672. The
hub shaft handle 326 can further include a hub shaft connector 673
(FIGS. 6B and 6C) positioned within the body component 670. The hub
shaft 316 (FIG. 4; not shown in FIGS. 6A-6C for clarity) is
configured to extend through the hub shaft lumen 671 and be secured
to the hub shaft connector 673. The valve lumen 672 can receive one
or more adaptors, valves, sealing members, etc., (not shown) that
are configured for maintaining hemostasis and/or facilitating the
ingress/egress of fluids (e.g., blood, priming solution, etc.) into
the hub shaft 316. In some embodiments, for example, a duckbill
hemostasis valve (not shown) is positioned in the valve lumen
672.
[0065] The gear assembly 680 includes a housing 681 (FIGS. 6A and
6B; omitted in FIG. 6C for clarity) that can at least partially
enclose the following components shown in FIG. 6C: a body portion
682, a pinion gear 683, a ring gear 684, and a release member 685.
The body component 670 and the gear assembly 680 (e.g., the housing
681, the body portion 682, and/or other components of the gear
assembly 680) together include/define an additional series of
interconnected lumens extending from the hub shaft connector 673
including (i) a release shaft lumen 674, (ii) a drive shaft lumen
675, (iii) a core shaft lumen 676, and (iv) one or more rail lumens
677. The core shaft 318 (FIG. 3; not shown in FIGS. 6A-6C for
clarity) extends through the hub shaft 316, the hub shaft connector
673, and the core shaft lumen 676 to the core shaft handle 328
(FIG. 3). Accordingly, the core shaft 318 passes entirely through
the hub shaft handle 326 and is independently movable relative to
the hub shaft handle 326 and the hub shaft 316. The rail lumens 677
are configured to slidably receive the rails 332 (FIG. 3; omitted
in FIGS. 6B and 6C for clarity).
[0066] The drive shaft 552 (FIGS. 5D-5F; not shown in FIGS. 6A-6C
for clarity) extends through the hub shaft 316, the hub shaft
connector 673, and the drive shaft lumen 675, and is fixedly
coupled to the pinion gear 683. Referring to FIG. 6C, in some
embodiments, the drive shaft 552 is secured to the pinion gear 683
via a set screw 686 and/or other suitable connection. The pinion
gear 683 can be operably coupled to the ring gear 684 via, for
example, the mating engagement of a plurality of teeth of the
pinion gear 683 and the ring gear 684. The ring gear 684 is
rotatable to rotate the pinion gear 683 to rotate the drive shaft
552. In some embodiments, the ring gear 684 includes a plurality of
gripping features 687 around a perimeter thereof and that are
accessible outside the housing 681. A user (e.g., a physician,
other clinician, robotic or other automated mechanism), can
manipulate the gripping features 687 to rotate the ring gear 684,
thereby driving rotation of the drive shaft 552 to, for example,
move the hub assembly 436 (FIGS. 5A-5F), as described in greater
detail below. In some aspects of the present technology, the
gripping features 687 accessible about its circumference to
facilitate easy gripping and rotation of the ring gear 684. In some
embodiments, the gear assembly 680 is configured to have a
selected/selectable amount of frictional drag that inhibits
rotation of the ring gear 684 to avoid rotation caused by
inadvertent contact. These friction inducing features (e.g.,
compressed O-rings) and/or gear locks (not shown) operably coupled
to the gear assembly 680 can avoid accidental rotation and promote
only purposeful actuation of the gear assembly 680.
[0067] The release shaft 562 (FIGS. 5D-5F; not shown in FIGS. 6A-6C
for clarity) extends through the hub shaft 316, the hub shaft
connector 673, and the release shaft lumen 674, and is fixed to the
release member 685 shown in FIG. 6C. The release shaft 562 can be
secured to the release member 685 via a set screw 688, other
mechanical connector, adhesive, welding, or other suitable
connection. The release member 685 can be releasably coupled the
gear assembly 680 and configured to be moved (e.g., pulled
proximally) away from the gear assembly 680 to move the release
shaft 562 in a proximal direction through the hub shaft handle 326.
In some embodiments, the release member 685 includes one or more
locking features (e.g., one or more threaded connections,
compressed O-rings, press-fittings) that must be disengaged to
permit movement of the release member 685 to, for example, inhibit
or even prevent accidental disengagement of the release member
685.
[0068] The operation of the hub shaft handle 326 and the hub
assembly 436 for deploying/releasing the implantable device 200 is
now described with reference to FIGS. 2A, 2B, and 4-6C. During
device delivery to a target site, the hub assembly 436 is in the
first position shown in FIGS. 5A and 5D such that all the
connectors 205 of the implantable device 200 are secured/restrained
in the first and second recesses 544, 546 by the outer hub
component 542. When the implantable device 200 is at the desired
target site (e.g., at or near the mitral valve), the user can
initiate deployment by moving the hub assembly 436 to the second
position shown in FIGS. 5B and 5E by actuating (e.g., rotating) the
ring gear 684 of the hub shaft handle 326 and, thereby, rotating
the drive shaft 552. Rotation of the drive shaft 552 rotates the
lead screw 555, which drives (e.g., linearly translates) the inner
hub component 540 toward and partially out of the distal opening
549 of the outer hub component 542 via the engagement of the
threaded outer surface 556 of the lead screw 555 with the threaded
portion 553 of the drive lumen 550. In the second position, at
least a portion of each second recess 546 (e.g., the second
portions 547 of the second recesses 546) is positioned sufficiently
distal of the distal opening 549 of the outer hub component 542
that the connectors 205 positioned at the posterior side portion P
of the implantable device 200 are no longer constrained by the
outer hub component 542, and thus free to disengage from the hub
assembly 436. While in the second position with the
posteriorly-positioned connectors 205 released, the second portions
547 of the first recesses 544 remain covered by the outer hub
component 542 such that the connectors 205 positioned at the
anterior side portion A of the implantable device 200 remain
constrained by the outer hub component 542. Accordingly, moving the
hub assembly 436 to second position disengages the struts 206 at
the posterior side portion P of the atrial-fixation member 202 from
the hub assembly 436--allowing them to expand--while inhibiting the
struts 206 at the anterior side portion A of the atrial-fixation
member 202 from disengaging the hub assembly 436 and expanding. In
some embodiments, the hub assembly 436 has other configurations
that allow for selective disengagement of the connectors 205 in a
different manner or order, such as the anteriorly-positioned
connectors 205 releasing before the posteriorly-positioned
connectors 205.
[0069] In some embodiments, in the second position, the lock pin
558 inhibits further distal movement of the inner hub component 540
(e.g., to the third position shown in FIGS. 5C and 5F). For
example, the release shaft 562 can bias the flared portion 559 of
the lock pin 558 radially outward and into engagement with the stop
surface 560 of the outer hub component 542, while the stop member
561 engages the stop surface 554 of the lock lumen 564. In some
aspects of the present technology, the lock pin 558 and the release
shaft 562 inhibit or even prevent inadvertent deployment of the
struts 206 at the anterior side portion A of the atrial-fixation
member 202 by inhibiting the first recesses 544 from being moved
distally past the distal opening 549 of the outer hub component 542
(e.g., to the third position shown in FIGS. 5C and 5F).
[0070] To move the move the hub assembly 436 to the third position
shown in FIGS. 5C and 5F, the user can first remove the release
shaft 562 from the release lumen 563 of the lock pin 558 by moving
(e.g., pulling) the release member 685 proximally away from the
gear assembly 680 of the hub shaft handle 326. The user can then
further actuate the ring gear 684 of the hub shaft handle 326 to
drive the drive shaft 552 to rotate. Removing the release shaft 562
removes the outward biasing force provided by the release shaft 562
when the flared portion 559 is urged inward, and thereby permits
the flared portion 559 of the lock pin 558 to move (e.g., flex)
radially inward and past the stop surface 560 of the outer hub
component 542 when the drive shaft 552 and the lead screw 555 drive
the inner hub component 540 distally. In the third position, the
first recesses 544 (e.g., the second portions 547 of the first
recesses 544) are positioned sufficiently distal of the distal
opening 549 of the outer hub component 542 that the connectors 205
positioned at the anterior side portion A of the implantable device
200 are no longer constrained by the outer hub component 542, and
are thus free to disengage the hub assembly 436. Accordingly,
moving the hub assembly 436 to third position disengages the struts
206 at the anterior side portion A of the atrial-fixation member
202 from the hub assembly 436, allowing them to expand. Therefore,
in some aspects of the present technology the hub assembly 436 is
configured to provide for a controlled, two-stage release of the
atrial-fixation member 202 in which the struts 206 at the posterior
side portion P are released from the hub assembly 436 and allowed
to expand before the struts 206 at the anterior side portion A. In
additional aspects of the present technology, the hub assembly 436
allows for the controlled and staged release of the atrial-fixation
member 202 from the distal end of the delivery system 310 (FIG. 3)
and is not affected or minimally affected by factors such as
catheter shaft compression, curving, and the like that could make
it difficult to control the release of the atrial-fixation member
202 with the same precision via control from the proximal end of
the delivery system 310.
[0071] FIGS. 7A and 7B are a partially-transparent isometric side
view and an enlarged partially cross-sectional side view,
respectively, of the plug assembly 438 at the distal end portion of
the delivery system 310 of FIGS. 3 and 4 in accordance with
embodiments of the present technology. Referring to FIGS. 7A and 7B
together, the plug assembly 438 includes a plug housing 790
configured to be secured to/at a distal terminus of the core shaft
318. The plug housing 790 includes a proximal end portion 791a and
a distal end portion 791b. In some embodiments, a section of the
plug housing 790 extends at least partially into a lumen 792
defined by the core shaft 318 and can be secured thereto via a
friction-fit arrangement, adhesive, laser-weld, fasteners, and/or
other suitable attachment mechanisms.
[0072] The plug assembly 438 further includes/defines a plurality
of lumens including a drive lumen 793, a clip tendon lumen 794, and
a cinch tendon lumen 795 (collectively "lumens 793-795"). In the
illustrated embodiment, the lumens 793-795 are defined by tubes
coupled to the plug housing 790 and that extend distally into the
lumen 792 of the core shaft 318. In some embodiments, the tubes are
short, flexible tubes while, in other embodiments the tubes can be
rigid or semi-rigid and/or can extend through the entire length of
the core shaft 318. In other embodiments, the lumens 793-795 can be
defined solely within the plug housing 790 and/or can extend
through a wall of the core shaft 318. For example, the plug housing
790 can be a single-piece, such as a plastic extrusion, that
defines each of the lumens 793-795.
[0073] The clip tendon lumen 794 is configured to receive a first
elongated flexible element, such as a suture, string, and/or a wire
(e.g., a clip tendon 821 shown in FIG. 8C) for actuating the clip
209 of the baffle 204 (FIGS. 2A and 2B), as described in further
detail below. The cinch tendon lumen 795 extends distally to the
flexible tube 437 and is configured to receive a second elongated
flexible element, such as a cinch tendon 439 (FIG. 4) for
controlling expansion and contraction of the atrial-fixation member
202. In some embodiments, one or both of the first and second
elongated flexible elements (e.g., the clip and cinch tendons) can
extend from the proximal portion of the delivery system 310 (FIG.
3) to the distal end portion, where they form a loop around an
element (e.g., connection features on the clip 209 (FIG. 2A) and/or
the atrial-fixation member 202 (FIGS. 2A and 2B)), and then extend
back up through the delivery system 310 to the proximal end (e.g.,
referred to as "double-length suture loops"). In these embodiments,
the clip tendon lumen 794 and/or the cinch tendon lumen 795 carry
two sections of the elongated flexible elements, and in certain
embodiments the tubes carrying the flexible elements divide the
lumens 794, 795 into separate channels that carry the individual
sections of the elongated flexible members to avoid entanglement or
excessive friction.
[0074] In the illustrated embodiment, the plug assembly 438
includes a baffle connection member 796, such as a threaded shaft
(e.g., a screw), secured to the plug housing 790 in a distal
portion of the drive lumen 793 and extending out of the drive lumen
793 beyond the distal end portion 791b of the plug housing 790. In
some embodiments, the baffle connection member 796 is rotatably
coupled within the drive lumen 793. With additional reference to
FIG. 4, the baffle connection member 796 is configured to extend
through the opening 201 in the baffle 204 to releasably engage the
delivery attachment member 203 (e.g., via a threaded connection) to
secure the core shaft 318 to the baffle 204 of the implantable
device 200. A drive shaft 798 can extend through the drive lumen
793 to operably couple the baffle connection member 796 to an
actuation means (e.g., a wheel, knob, button) at the proximal
portion of the delivery system 310 (FIG. 3), which can be actuated
to impart rotation on the baffle connection member 796, thereby
disengaging the baffle connection member 796 from the delivery
attachment member 203. The drive shaft 798 can be coupled to the
baffle connection member 796 via welding, adhesives, fasteners,
and/or other suitable types of connections, or be manufactured from
a single piece of wire.
[0075] The clip tendon, the cinch tendon 439, and the drive shaft
798 extend from the plug assembly 438, through the core shaft 318,
and to the core shaft handle 328. FIGS. 8A-8D are a distally-facing
isometric view, a partially transparent side view, a partially
transparent top view, and a partially transparent proximally-facing
isometric view, respectively, of the core shaft handle 328
configured in accordance with embodiments of the present
technology. In general, the core shaft handle 328 is configured to
be manipulated/actuated by a user to individually actuate (i) the
clip tendon to open/close the clip 209 (FIGS. 2A and 2B), (ii) the
drive shaft 798 to unscrew the baffle connection member 796 (FIGS.
7A and 7B) from the baffle 204 (FIGS. 2A and 2B), and (iii) the
cinch tendon 439 to cinch/uncinch the atrial-fixation member 202
(FIGS. 2A and 2B).
[0076] Referring to FIGS. 8A-8D together, the core shaft handle 328
includes a core shaft housing 802 and a plurality of actuators
coupled to the core shaft housing 802, including, for example, a
baffle actuator 804, a clip actuator 806, and a cinch actuator 808.
The housing 802 is shown as partially transparent in FIGS. 8B-8D.
The housing 802 and/or other components of the core shaft handle
328 define a series of interconnected lumens including a core shaft
lumen 812, a valve lumen 814, and an actuation lumen 816
(collectively "lumens 812-816"). The core shaft handle 328 further
includes a core shaft connector 818 positioned between the lumens
812-816. The core shaft 318 is configured to extend through the
core shaft lumen 812 and be secured to the core shaft connector
818. The valve lumen 814 is configured to receive a valve 819
and/or one or more additional adaptors, valves, sealing members,
and/or other fluid control components for, for example, maintaining
hemostasis, facilitating the ingress/egress of fluids (e.g., blood,
priming solution, saline) into the core shaft 318, etc. The rails
332 can be secured to the housing 802 and/or other components of
the core shaft handle 328 to slidably couple the core shaft handle
328 to the hub shaft handle 326 (FIG. 3).
[0077] The drive shaft 798 can extend through the core shaft 318,
the core shaft connector 818, and into the actuation lumen 816
where it is secured to the baffle actuator 804. The baffle actuator
804 is accessible to a user via the housing 802 at a proximal
portion of the core shaft handle 328 and is actuatable to drive the
drive shaft 798. In the illustrated embodiment, for example, the
baffle actuator 804 can be rotated to rotate the drive shaft 798.
Accordingly, with additional reference to FIGS. 4, 7A, and 7B, a
user (e.g., a physician) can grip and rotate the baffle actuator
804 to impart rotation onto the drive shaft 798, which in turn
rotates the baffle connection member 796 to disengage the baffle
connection member 796 from the delivery attachment member 203 and,
thereby, disengages/detaches the baffle 204 from the core shaft
318.
[0078] In the illustrated embodiment, the core shaft handle 328
includes a clip mount assembly 820 and a cinch mount assembly 830
slidably positioned within the actuation lumen 816. The clip mount
assembly 820 is operably coupled to the clip actuator 806 and the
cinch mount assembly 830 is operably coupled to the cinch actuator
808. FIGS. 8E-8H are a partially transparent side view, a
proximally-facing front view, a distally-facing isometric view, and
another distally-facing isometric view, respectively, of the clip
mount assembly 820 and the cinch mount assembly 830 configured in
accordance with embodiments of the present technology. The cinch
mount assembly 830 is in (i) a relaxed (e.g., first, non-tensioned,
minimally-tensioned) configuration in FIGS. 8E and 8G and (ii) a
tensioned (e.g., second) configuration in FIGS. 8F and 8H.
[0079] Referring to FIGS. 8E-8H together, the clip mount assembly
820 can include a body 822, a clip tendon mount 824 fixed to the
body 822, and a latch 840 movably (e.g., pivotally) coupled to the
body 822 via, for example, a shaft 842. The latch 840 is omitted in
FIG. 8H for clarity. The clip actuator 806 can be coupled to the
latch 840 and slidably mounted to a first slot 803 (FIGS. 8A-8D)
extending through/along the housing 802. With additional reference
to FIG. 8C, the clip tendon (e.g., a clip tendon 821 shown in FIG.
8C) extends through the core shaft 318, the core shaft connector
818, and into the actuation lumen 816 where it is releasably
coupled to the clip tendon mount 824. In the illustrated
embodiment, for example, the clip tendon mount 824 comprises a post
841 and a screw 843. The clip tendon 821 can be a double-length
suture loop that is wound around the post 841 (e.g., one time, two
times, ten times, more than ten times) and then secured to the body
822 via the screw 843. As best seen in FIGS. 8E and 8H, the latch
840 can include a plurality of first engagement features 845 (e.g.,
teeth, grooves) and can be operably coupled to the body 822 via a
biasing member 846, such as a compression spring. As best seen in
FIGS. 8A and 8B, the housing 802 can include a plurality of second
engagement features 847 (e.g., teeth, grooves) positioned adjacent
to the first slot 803 within the actuation lumen 816. Referring to
FIGS. 8A, 8B, 8E, and 8H together, the biasing member 846 can
normally bias the first engagement features 845 into engagement
with the second engagement features 847 to inhibit movement of the
clip actuator 806 and the clip mount assembly 820 along the first
slot 803. To move the clip mount assembly 820 through the actuation
lumen 816, a user can depress the clip actuator 806 against the
biasing force of the biasing member 846 to disengage the first
engagement features 845 from the second engagement features 847 and
then slide the clip actuator 806 along the first slot 803.
[0080] Referring again to FIGS. 8A-8D together, during a delivery
procedure, actuation of the clip actuator 806 can drive the clip
mount assembly 820 within the actuation lumen 816 to drive/tension
the clip tendon 821 to open/close the clip 209 (FIG. 2B). More
specifically, FIGS. 8A-8D illustrate the clip actuator 806 in a
first position in which the clip actuator 806 is positioned
proximate a distal end portion of the first slot 803. In operation,
the user can depress the clip actuator 806 and slide the clip
actuator 806 along the first slot 803 toward a second position
proximate a proximal end portion of the first slot 803 (e.g., in a
direction indicated by arrow P in FIG. 8A). This proximal movement
of the clip actuator 806 can pull the clip tendon 821 to open the
clip 209. Likewise, distal movement of the clip actuator 806 can
release the force/tension on the clip tendon 821, thereby allowing
the normally-closed clip 209 to close. In some embodiments, the
first slot 803 can have a length selected to correspond to a
specific opening/closing stroke of the clip 209. For example, a
position of the distal end portion of the first slot 803 can be
selected to correspond to a fully-closed position of the clip 209
and/or a position of the proximal end portion of the first slot 803
can be selected to correspond to a fully-open position of the clip
209. In other embodiments, the core shaft handle 328 can include
other features for actuating the clip tendon 821 to open/close the
clip 209, such as one or more buttons, levers, knobs, sliders,
and/or other actuation members.
[0081] Referring again to FIGS. 8E-8H together, the cinch mount
assembly 830 can include a body 832, a cinch tendon mount 834
(shown partially transparent in FIG. 8E for clarity), and a biasing
member 836 (FIG. 8E) operably coupling the cinch tendon mount 834
to the body 832. In the illustrated embodiment, the body defines a
channel 850 and the cinch tendon mount 834 is slidably mounted
within the channel 850. With additional reference to FIG. 8C, the
cinch tendon 439 (FIG. 8C) extends through the core shaft 318, the
core shaft connector 818, and into the actuation lumen 816 where it
is coupled to the cinch tendon mount 834. In the illustrated
embodiment, for example, the clip tendon mount 824 includes a post
851 and a screw 853 (both obscured in FIGS. 8E and 8H), and the
cinch tendon 439 can be wound around the post 851 and further
secured (e.g., clamped) via the screw 853.
[0082] Referring again to FIGS. 8A-8D together, the cinch actuator
808 can be a ring gear that is accessible from the housing 802 for
actuation by a user. The cinch actuator 808 can be operably coupled
to the cinch mount assembly 830 via a pinion gear 835 and a lead
screw 837. More specifically, the pinion gear 835 can be coupled to
the cinch actuator 808 via, for example, the mating engagement of a
plurality of teeth of the pinion gear 835 and the cinch actuator
808. The pinion gear 835 can be fixedly mounted to the lead screw
837, which can threadedly engage the cinch mount assembly 830
(e.g., the body 832). Accordingly, with additional reference to
FIG. 4, the user can grip and rotate the cinch actuator 808 to (i)
drive the lead screw 837 to rotate, (ii) drive the cinch mount
assembly 830 to move (e.g., translate) within the actuation lumen
816, and (iii) drive/tension the cinch tendon 439 to cinch/uncinch
the atrial-fixation member 202 of the implantable device 200 (FIGS.
2A and 2B). For example, the cinch mount assembly 830 is in a first
position in FIGS. 8A-8D in which the cinch mount assembly 830 is
positioned proximate a distal portion of the actuation lumen 816.
In operation, rotation of the cinch actuator 808 in a first
direction can drive the cinch mount assembly 830 proximally through
the actuation lumen 816 to pull the cinch tendon 439 proximally to
radially compress the atrial-fixation member 202. Conversely,
rotation of the cinch actuator 808 in a second direction can drive
the cinch mount assembly 830 distally through the actuation lumen
816 to relax the cinch tendon 439 to permit the atrial-fixation
member 202 to radially expand.
[0083] Referring to FIGS. 8A-8H together, in some embodiments the
biasing member 836 stores energy (e.g., becomes "loaded") as the
cinch mount assembly 830 is driven proximally through the actuation
lumen 816. In some embodiments, the biasing member 836 can be a
compression spring that compresses due to the opposing forces
between the body 832 (e.g., via the lead screw 837) and the cinch
tendon mount 834 (e.g., via the cinch tendon 439). In the
illustrated embodiment, the cinch tendon mount 834 includes a cinch
indicator portion 810 that can be viewed through, for example, a
second slot 809 extending through/along the housing 802. A distance
between the cinch indicator portion 810 of the cinch tendon mount
834 and the body 832 can indicate a relative amount of cinching.
For example, in the relaxed position shown in FIGS. 8E and 8G, the
biasing member 836 can bias the cinch tendon mount 834 away from
the body 832--increasing the distance between the cinch indicator
portion 810 and the body 832. Conversely, in the tensioned position
shown in FIGS. 8F and 8H, the cinching forces can compress the
biasing member 836--decreasing the distance between the cinch
indicator portion 810 and the body 832. Accordingly, the user can
view the positioning of the cinch indicator portion 810 along the
second slot 809 to determine an amount of cinching.
[0084] In additional aspects of the present technology, the biasing
member 836 of the cinch mount assembly 830 is configured to
spring-load the cinch tendon 439 such that tension is maintained on
the cinch tendon 439 during manipulation of the delivery system
310. With additional reference to FIGS. 2A and 2B, this can inhibit
or even prevent unwanted cinching/uncinching of the atrial-fixation
member 202. In some embodiments, for example, actuating the cinch
actuator 808 to cinch the implantable device 200 can load the
biasing member 836 such that the biasing member 836 can take up any
slack in the cinch tendon 439 during manipulation of the delivery
system 310. In other embodiments, the core shaft handle 328 can
include other features for actuating the cinch tendon 439 to
cinch/uncinch the implantable device 200, such as one or more
buttons, levers, knobs, sliders, and/or other actuators. For
example, in some embodiments the cinch tendon 439 can be actuated
via the same or a similar arrangement as the clip tendon 821 (e.g.,
via sliding movement of the cinch actuator 808 along the housing
802).
[0085] In some embodiments, the clip tendon mount 824 of the clip
mount assembly 820 and the cinch tendon mount 834 of the cinch
mount assembly 830 are each nearly aligned with a longitudinal
axis/centerline of the core shaft handle 328. This arrangement can
help ensure that the tension/drive forces on the cinch tendon 439
and the clip tendon 821 (collectively "tendons 439, 821") are
relatively aligned along the axes of the tendons 439, 821 and help
inhibit shear or other forces that could prematurely break the
tendons 439, 821. In some aspects of the present technology, the
clip mount assembly 820 and the cinch mount assembly 830 are
independently movable through the actuation lumen 816. For example,
in the illustrated embodiment the body 822 of the clip mount
assembly 820 and the body 832 of the cinch mount assembly 830 each
have complementary shapes (e.g., generally L-shapes) that allow the
clip and cinch mount assemblies 820, 830 to move through the
actuation lumen 816 without interfering with one another. In other
embodiments, the clip and cinch mount assemblies 820, 830 can be
operably coupled to move together.
[0086] Referring to FIG. 8C, the housing 802 can further include an
opening 805 configured (e.g., shaped, sized, and/or positioned) to
provide access to the tendons 439, 821. In operation, for example,
the user can remove the tendons 439, 821 by (i) cutting the tendons
439, 821 by inserting a cutting tool through the opening 805 and
(ii) pulling the tendons 439, 821 out of the opening 805. In other
embodiments, the core shaft handle 328 can have other features for
cutting and/or removing the tendons 439, 821. In some embodiments,
the housing 802 further includes a removable cover 807 that can be
releasably secured over the opening 805 (e.g., via a snap-fit
arrangement) to conceal the tendons 439, 821 and enclose the
internal features the core shaft handle 328.
[0087] FIGS. 14A-14D are a distally-facing isometric view, a
partially transparent side view, a partially transparent enlarged
side view, and a partially transparent proximally-facing isometric
view, respectively, of a core shaft handle 1428 configured in
accordance with additional embodiments of the present technology.
The core shaft handle 1428 can (i) include several features
generally similar or identical to the core shaft handle 328
described in detail above with reference to FIGS. 8A-8H, (ii)
operate generally similarly or identically to the core shaft handle
328, and/or (iii) can be integrated into the system 310 in a
generally similar or identical manner. Referring to FIGS. 14A-14D
together, the core shaft handle 1428 includes a core shaft housing
1402 and a plurality of actuators coupled to the core shaft housing
1402, including, for example, a baffle actuator 1404, a clip
actuator 1406, and a cinch actuator 1408. The housing 1402 and/or
other components of the core shaft handle 1428 define a series of
interconnected lumens including a core shaft lumen 1412, a valve
lumen 1414, and an actuation lumen 1416 (collectively "lumens
1412-1416"). As best seen in FIG. 14B, the core shaft handle 1428
further includes a core shaft connector 1418 positioned between the
lumens 1412-1416. The core shaft 318 (FIG. 3; not shown in FIGS.
14A-8D for the sake of clarity) is configured to extend through the
core shaft lumen 1412 and be secured to the core shaft connector
1418. The valve lumen 1414 is configured to receive one or more
adaptors, valves, sealing members, and/or other fluid control
components (not shown) for, for example, maintaining hemostasis,
facilitating the ingress/egress of fluids (e.g., blood, priming
solution, saline) into the core shaft 318, and the like. As best
seen in FIGS. 14A and 14B, the rails 332 can be secured to the
housing 1402 and/or other components of the core shaft handle 1428
to slidably couple the core shaft handle 1428 to the hub shaft
handle 326.
[0088] The drive shaft 798 can extend through the core shaft 318,
the core shaft connector 1418, and into the actuation lumen 1416
where it is secured to the baffle actuator 1404. The baffle
actuator 1404 is accessible to a user via the housing 1402 at a
proximal portion of the core shaft handle 1428 and is actuatable to
drive the drive shaft 798. In the illustrated embodiment, for
example, the baffle actuator 1404 can be rotated to rotate the
drive shaft 798. Accordingly, with additional reference to FIGS. 4,
7A, and 7B, a user (e.g., a physician) can grip and rotate the
baffle actuator 1404 to impart rotation onto the drive shaft 798,
which in turn rotates the baffle connection member 796 to disengage
the baffle connection member 796 from the delivery attachment
member 203 and, thereby, disengages/detaches the baffle 204 from
the core shaft 318.
[0089] In the illustrated embodiment, the core shaft handle 1428
includes a clip mount assembly 1420 slidably positioned within the
actuation lumen 1416. The clip tendon (e.g., a clip tendon 1421
shown in FIG. 14C) extends through the core shaft 318, the core
shaft connector 1418, and into the actuation lumen 1416 where it is
releasably coupled to the clip mount assembly 1420. In some
embodiments, the clip mount assembly 1420 includes a body 1422, a
clip tendon mount 1424, and a biasing member 1426 operably coupling
the clip tendon mount 1424 to the body 1422. The body 1422 is shown
as partially transparent in FIGS. 14B and 14D for clarity. The clip
actuator 1406 can be slidably mounted to a first slot 1403
extending through/along the housing 1402, and is operably coupled
to the clip mount assembly 1420 through the first slot 1403. In the
illustrated embodiment, the clip tendon 1421 is a double-length
suture loop that extends through an eyelet 1423 in the clip tendon
mount 1424.
[0090] During a delivery procedure, actuation of the clip actuator
1406 can drive the clip mount assembly 1420 within the actuation
lumen 1416 to drive/tension the clip tendon 1421 to open/close the
clip 209 (FIG. 2B). More specifically, FIGS. 14A-14D illustrate the
clip actuator 1406 in a first position in which the clip actuator
1406 is positioned proximate a distal end portion of the first slot
1403. In operation, the user can grip the clip actuator 1406 and
slide the clip actuator 1406 along the first slot 1403 toward a
second position proximate a proximal end portion of the first slot
1403 (e.g., in a direction indicated by arrow Pin FIG. 14A). This
proximal movement of the clip actuator 1406 can pull the clip
tendon 1421 to open the clip 209. Likewise, distal movement of the
clip actuator 1406 can release the force/tension on the clip tendon
1421, thereby allowing the normally-closed clip 209 to close. In
some embodiments, the first slot 1403 can have a length selected to
correspond to a specific opening/closing stroke of the clip 209.
For example, a position of the distal end portion of the first slot
1403 can be selected to correspond to a fully-closed position of
the clip 209 and/or a position of the proximal end portion of the
first slot 1403 can be selected to correspond to a fully-open
position of the clip 209. In some embodiments, the biasing member
1426 stores energy (e.g., becomes "loaded") as the clip mount
assembly 1420 is driven proximally through the actuation lumen
1416. In various embodiments, the core shaft handle 1428 can
include other features for actuating the clip tendon 1421 to
open/close the clip 209, such as one or more buttons, levers,
knobs, sliders, and/or other actuation members.
[0091] As further shown in FIGS. 14B-14D, the core shaft handle
1428 can also include a cinch mount assembly 1430 slidably
positioned within the actuation lumen 1416. The cinch mount
assembly 1430 can include features generally similar or identical
to those of the clip mount assembly 1420. In the illustrated
embodiment, for example, the cinch mount assembly 1430 includes a
body 1432 (shown partially transparent in FIGS. 14B and 14D for
clarity), a cinch tendon mount 1434, and a biasing member 1436
operably coupling the cinch tendon mount 1434 to the body 1432. The
cinch tendon 439 extends through the core shaft 318, the core shaft
connector 1418, and into the actuation lumen 1416 where it is
coupled to the cinch tendon mount 1434 via an eyelet 1433 formed
therein.
[0092] In some embodiments, as best seen in FIG. 14D, the cinch
actuator 1408 is a ring gear that is accessible from the housing
1402 for actuation by a user. The cinch actuator 1408 can be
operably coupled to the cinch mount assembly 1430 via a pinion gear
1435 and a lead screw 1437. More specifically, the pinion gear 1435
can be coupled to the cinch actuator 1408 via, for example, the
mating engagement of a plurality of teeth of the pinion gear 1435
and the cinch actuator 1408. The pinion gear 1435 can be fixedly
mounted to the lead screw 1437, which can threadedly engage the
cinch mount assembly 1430 (e.g., the body 1432). Accordingly, with
additional reference to FIG. 4, the user can grip and rotate the
cinch actuator 1408 to (i) drive the lead screw 1437 to rotate,
(ii) drive the cinch mount assembly 1430 to move (e.g., translate)
within the actuation lumen 1416, and (iii) drive/tension the cinch
tendon 439 to cinch/uncinch the atrial-fixation member 202 of the
implantable device 200. For example, the cinch mount assembly 1430
is in a first position in FIGS. 14A-14D in which the cinch mount
assembly 1430 is positioned proximate a distal portion of the
actuation lumen 1416. In operation, rotation of the cinch actuator
1408 in a first direction can drive the cinch mount assembly 1430
proximally through the actuation lumen 1416 to pull the cinch
tendon 439 proximally to radially compress the atrial-fixation
member 202 (FIGS. 2A and 2B). Conversely, rotation of the cinch
actuator 1408 in a second direction can drive the cinch mount
assembly 1430 distally through the actuation lumen 1416 to relax
the cinch tendon 439 to permit the atrial-fixation member 202 to
radially expand. In some embodiments, the biasing member 1436
stores energy (e.g., becomes "loaded") as the cinch mount assembly
1430 is driven proximally through the actuation lumen 1416.
[0093] In various embodiments, the core shaft handle 1428 can
include other features for actuating the cinch tendon 439 to
cinch/uncinch the implantable device 200, such as one or more
buttons, levers, knobs, sliders, and/or other actuators. For
example, in some embodiments the cinch tendon 439 can be actuated
via the same or a similar arrangement as the clip tendon 1421
(e.g., via sliding movement of the cinch actuator 1408 along the
housing 1402).
[0094] In some aspects of the present technology, the clip mount
assembly 1420 and the cinch mount assembly 1430 are independently
movable through the actuation lumen 1416. For example, in the
illustrated embodiment the body 1422 of the clip mount assembly
1420 and the body 1432 of the cinch mount assembly 1430 each have
complementary shapes (e.g., semi-circular cross-sectional shapes)
that allow the clip and cinch mount assemblies 1420, 1430 to move
through the actuation lumen 1416 without interfering with one
another. In other embodiments, the clip and cinch mount assemblies
1420, 1430 can be operably coupled to move together.
[0095] In another aspect of the present technology, the biasing
member 1426 of the clip mount assembly 1420 and the biasing member
1436 of the cinch mount assembly 1430 are configured to spring-load
the clip tendon 1421 and the cinch tendon 439 (collectively
"tendons 439, 1421"), respectively, such that tension is maintained
on the tendons during manipulation of the delivery system 310. With
additional reference to FIGS. 2A and 2B, this can inhibit or even
prevent unwanted actuation of the clip 209 or cinching/uncinching
of the atrial-fixation member 202. In some embodiments, for
example, actuating the cinch actuator 1408 to cinch the implantable
device 200 can load the biasing member 1436 such that the biasing
member 1436 can take up any slack in the cinch tendon 439 during
manipulation of the delivery system 310. In another aspect of the
present technology, the clip tendon mount 1424 of the clip mount
assembly 1420 and the cinch tendon mount 1434 of the cinch mount
assembly 1430 are each nearly aligned with a longitudinal
axis/centerline of the core shaft handle 1428. This arrangement can
help ensure that the tension/drive forces on the tendons 439, 1421
are relatively aligned along the axes of the tendons 439, 1421 and
help inhibit shear or other forces that could prematurely break the
tendons 439, 1421.
[0096] Referring to FIGS. 14B and 14D together, the housing 1402
can further include an opening 1405 configured (e.g., shaped,
sized, and/or positioned) to provide access to the tendons 439,
1421. In operation, for example, the user can remove the tendons
439, 1421 by (i) cutting the tendons 439, 1421 by inserting a
cutting tool through the opening 1405 and (ii) pulling the tendons
439, 1421 out of the opening 1405. In other embodiments, the core
shaft handle 1428 can have other features for cutting/removing the
tendons 439, 1421. In some embodiments, the housing 1402 further
includes a removable cover 1407 (FIGS. 14A, 14C, and 14D) that can
be releasably secured over the opening 1405 (e.g., via a snap-fit
arrangement) to conceal the tendons 439, 1421 and enclose the
internal features the core shaft handle 1428.
[0097] In the illustrated embodiment, a cinch indicator 1410 is
coupled to the cinch mount assembly 1430 and extends at least
partially out of a second slot 1409 extending through/along the
housing 1402. For example, the cinch indicator 1410 can be coupled
to the body 1432 of the cinch mount assembly 1430 via a threaded
fastener or other suitable fastener. In operation, the cinch
indicator 1410 moves along the second slot 1409 as the cinch
actuator 1408 drives movement of the cinch mount assembly 1430
through the actuation lumen 1416. The user can view the position of
the cinch indicator 1410 along the second slot 1409 to determine an
amount of cinching. In some embodiments, the second slot 1409 can
have a length selected to provide a maximum/minimum amount of
cinching of the atrial-fixation member 202. For example, a position
of a distal end portion of the second slot 1409 can be selected to
correspond to a minimum amount of cinching and/or a position of a
proximal end portion of the second slot 1409 can be selected to
correspond to a maximum amount of cinching. In some embodiments,
the cinch indicator 1410 can inhibit or even prevent rotation of
the cinch mount assembly 1430 within the actuation lumen 1416.
[0098] Referring to FIGS. 3-8H and 13A-14D together, the various
components of the delivery system 310 can be formed from metals
(e.g., stainless steel, nickel-titanium alloys, etc.), plastics,
and/or other suitable materials. The various components can be
manufactured using three-dimensional printing, injection molding,
machining, and/or other suitable processes known in the art.
Moreover, the various means of actuation can be combined or changed
without deviating from the scope of the present technology.
III. Selected Embodiments of Methods of Delivering Implantable
Devices
[0099] FIG. 9 is a flow diagram of a process or method 940 for
operating the delivery system 310 (FIGS. 3A-8D, 13A, and 13B) to
implant the implantable device 200 (FIGS. 2A, 2B and 4) at a target
site within a patient (e.g., at a native mitral valve of a human
patient) in accordance with embodiments of the present technology.
FIGS. 10A-10I are side views illustrating the implantable device
200 and a distal portion of the delivery system 310 during various
stages of the method 940 in accordance with embodiments of the
present technology. Although some features of the method 940 are
described in the context of the embodiments shown in FIGS. 2A-8H,
13A, and 13B for the sake of illustration, one skilled in the art
will readily understand that the method 900 can be carried out
using other suitable systems and/or devices described herein (e.g.,
including the core shaft handle 1428 described in detail with
reference to FIGS. 14A-14D). Likewise, although the method 940 is
described in the context of delivering the implantable device to a
native mitral valve, the method 940 can be employed to deliver
implantable devices to other locations (e.g., to other cardiac
valves) of a patient.
[0100] At block 941, the method 940 includes positioning the guide
catheter 312 proximate a left atrium of a patient. For example,
referring to FIG. 10A, the guide catheter 312 can be inserted to
traverse the venous system (e.g., via femoral or axillary access)
to the right atrium and then across the interatrial septum S into
the left atrium LA via a trans-septal approach (or through the
atrial roof in a trans-atrial approach). In some embodiments, a
distal portion of the guide catheter 312 can be positioned so that
its distal-most end (e.g., the end furthest from the user) is in
the left atrium LA. For example, the guide catheter 312 can extend
to a location as shown in FIG. 10A, or the guide catheter 312 can
be positioned further in the left atrium LA to extend at least
generally along the flow axis of the native cardiac valve (e.g., a
generally vertical axis VA in FIG. 10A). This alignment can be
achieved via a combination of torqueing/steering the guide catheter
312 using the guide catheter handle 322, pre-shaping the end of the
guide catheter 312, and/or flexing the guide catheter 312. However,
in some embodiments, the guide catheter 312 may not have such
complete steerability and its distal tip positioning may be more
approximate such that the delivery catheter 314, the hub shaft 316,
and/or the core shaft 318 (positioned within the guide catheter
312) can provide additional positioning at the desired location
across the septum S.
[0101] At block 942, the method 940 continues by advancing the
delivery catheter 314 (including the implantable device 200
compressed therein), the hub shaft 316, and the core shaft 318
through the guide catheter 312 into the left atrium LA as shown in
FIG. 10B. Once positioned within the left atrium LA, the method 940
includes unsheathing the implantable device 200 from the delivery
catheter 314 (block 943). For example, FIG. 10C shows the
implantable device 200 after being at least partially unsheathed,
which allows the atrial-fixation member 202 and the baffle 204 to
at least partially expand in the left atrium LA. The implantable
device 200 can be unsheathed by proximally retracting the delivery
catheter 314 relative to the implantable device 200. In other
embodiments, the implantable device 200 can be unsheathed by
distally advancing the implantable device 200 relative to the
delivery catheter 314 (e.g., via advancement of the hub shaft 316
and the core shaft 318 relative to the delivery catheter 314) in
addition to or alternatively to retracting the delivery catheter
314.
[0102] At block 944, the method 940 includes longitudinally/axially
compressing (e.g., flattening, shortening) the implantable device
200. For example, FIG. 10D shows the implantable device 200 after
being compressed. Longitudinally compressing the implantable device
200 includes decreasing a distance between (i) the superior end
portion S and the inferior end portion I and (ii) the plug assembly
438 and the core shaft 318. To longitudinally compress the
implantable device 200, the user can move the hub shaft 316 and/or
the core shaft 318 relative to one another to shorten the distance
between the hub assembly 436 of the hub shaft 316 and the plug
assembly 438 of the core shaft 318. For example, the user can move
the hub shaft handle 326 and/or the core shaft handle 328 toward
one another along the support assembly 320. In one aspect of the
present technology, longitudinally compressing the implantable
device 200 makes the implantable device 200 easier to rotate,
translate, and/or position within the space constraints of the left
atrium LA. In some embodiments, the implantable device 200 can be
axially compressed by more than about 20%, more than about 50%, or
more than about 70% relative to its length while compressed in the
delivery catheter (block 942) and/or after being unsheathed in the
left atrium LA (block 943). In other embodiments, block 943 can be
omitted and the implantable device 200 need not be compressed
longitudinally.
[0103] At block 945 the method 940 can include advancing the
delivery catheter 314 distally toward the implantable device 200
such that the delivery catheter 314 is positioned near/over the hub
assembly 436 which constrains the struts 206 at the superior end
portion S of the implantable device 200. More specifically, the
distal end portion of the delivery catheter 314 can be positioned
over the hub assembly 436 while the compressed atrial fixation
member 202 can at least partially surround the distal end portion
of the delivery catheter 314. In some aspects of the present
technology, positioning the delivery catheter 314 at least
partially over the implantable device 200 can aid in steering the
implantable device 200 within the left atrium LA by providing
additional rigidity, pushability, and/or torqueability to the
implantable device 200.
[0104] At block 946, the method 940 includes steering the
implantable device 200 toward the mitral valve of the patient, such
that the inferior end portion I of the implantable device 200 is
directed toward the mitral valve annulus, and aligning the
implantable device 200 with a portion of one or more desired native
leaflets. For example, FIGS. 10E and 1OF show the implantable
device 200 during and after steering, respectively, the implantable
device 200 toward a mitral valve MV and aligning the implantable
device 200 with a native leaflet (e.g., the middle scallop P2 of
the posterior leaflet) of the mitral valve MV. In some embodiments,
the spine 378 of the delivery catheter 314 can help facilitate
steering the implantable device 200 toward the mitral valve MV even
within the relatively small space of the left atrium LA.
[0105] At block 947, after the implantable device 200 is
rotationally and radially aligned with the portion of the desired
leaflet, the method 940 includes advancing the implantable device
200 at least partially across the mitral valve MV and capturing the
portion of the desired leaflet. For example, the implantable device
200 can be steered to the target site such that the implantable
device 200 crosses the mitral valve annulus with the
atrial-fixation member 202 positioned at least partially above the
annulus in the left atrium LA and the coaptation member 204
positioned at or below the annulus in the left ventricle LV. FIGS.
10G and 10H show the implantable device 200 during and after
capture of the middle scallop P2 of the posterior leaflet with the
clip 209. In some embodiments, the clip 209 can be opened before or
after crossing the mitral MV as shown in FIG. 10G, and then closed
to capture the middle scallop P2 of the posterior leaflet between
the clip 209 and the baffle 204. As described in detail above with
reference to FIGS. 2A, 2B, and 8A-8D, the user can open and close
the clip 209 by actuating (e.g., depressing and then sliding) the
clip actuator 806 of the core shaft handle 328. In some
embodiments, the clip 209 can be opened to help orient the
implantable device 200 within the left atrium LA.
[0106] In general, to steer the implantable device 200 to capture
the desired native leaflet (blocks 946 and 947), the user can
manipulate one or more of the handles 322-328. For example, the
user can manipulate the guide catheter handle 322 and/or the
delivery catheter handle 324 to advance and/or deflect the guide
catheter 312 and/or the delivery catheter 314 in one or more
directions--such as in a direction toward the mitral valve MV--to
facilitate positioning of the implantable device 200. In some
embodiments, re-advancing the delivery catheter 314 toward the
implantable device 200, as shown in FIG. 10E, facilitates
positioning/steering of the implantable device via manipulation of
the delivery catheter 314. Moreover, the implantable device 200 can
be oriented as desired by rotating, for example, the hub shaft
handle 326 and the core shaft handle 328 together relative to the
delivery catheter 314. For example, with additional reference to
FIG. 3, the hub shaft handle 326 and the core shaft handle 328 can
be rotated together about the second mount 327b and the third mount
327c, respectively. In some embodiments, because the hub shaft
handle 326 and the core shaft handle 328 are coupled together via
the rails 332, rotating one of the handles also rotates the other
one of the handles.
[0107] Once the implantable device 200 is correctly positioned
across the mitral valve MV with the coaptation member 204 in place
with respect to the native leaflets, the method 940 can continue at
block 948 by allowing the atrial-fixation member 202 to expand
within the left atrium LA above the mitral valve MV by uncinching
the atrial-fixation member 202. For example, FIG. 10H shows the
implantable device 200 after uncinching the atrial-fixation member
202. The user can uncinch the atrial-fixation member 202 by
rotating the cinch actuator 808 to release tension from the cinch
tendon 439. In some embodiments, the atrial-fixation member 202
does not contact the walls of the left atrium LA after being
uncinched, or only a portion of the atrial-fixation member 202
contacts tissue within the left atrium LA (e.g., the posterior
aspect of the left atrium LA).
[0108] At block 949, the method 940 includes determining/assessing
whether the implantable device 200 is properly positioned and
functioning properly. The performance of the implantable device
200, such as a reduction in an amount of mitral regurgitation, can
be evaluated via transesophageal echocardiography ("TEE") imaging
or another suitable technique.
[0109] At block 950, if the implantable device 200 is not
functioning properly, the implantable device can be repositioned or
recovered and removed from the patient. For example, the cinch
actuator 808 can be actuated to radially compress the
atrial-fixation member 202. Then, the clip 209 can be opened to
release the native leaflet by actuating (e.g., sliding) the clip
actuator 806 of the core shaft handle 328, and the implantable
device 200 can be retracted into the left atrium LA. The
implantable device 200 can then either be repositioned or removed.
Prior to removal, in some embodiments the implantable device 200
can be elongated along its longitudinal axis by moving the hub
shaft handle 326 and/or the core shaft handle 328 to move the hub
shaft 316 and/or the core shaft 318 relative to one another to
lengthen the distance between the hub assembly 436 of the hub shaft
316 and the plug assembly 438 of the core shaft 318. Elongating the
implantable device 200 further radially compresses the implantable
device 200. Finally, the implantable device 200 can be retracted
into the guide catheter 312 and removed from the patient.
[0110] If the clinician decides that the implantable device 200 is
functioning properly, the method 940 can continue to block 951 in
which the implantable device 200 is fully released/detached from
the delivery system 310. More specifically, FIG. 11 is a flow
diagram illustrating a process or method 1160 for releasing the
implantable device at block 951 in accordance with embodiments of
the present technology. FIGS. 12A-12D are side views illustrating
the implantable device 200 and a distal portion of the delivery
system 310 during various stages of the release method 1160 in
accordance with embodiments of the present technology.
[0111] At block 1161, the release method 1160 includes detaching
the baffle 204 from the delivery system 310, and more specifically
from the core shaft 318. Detaching the baffle 204 can include
actuating the baffle actuator 804 of the core shaft handle 328 to
unscrew the baffle connection member 796 from the delivery
attachment member 203 positioned within the hollow interior of the
baffle 204. In some embodiments, the baffle 204 can be detached
from the core shaft 318 prior to uncinching of the implantable
device 200 (block 948 of FIG. 9). In some embodiments, the tendons
439, 821 can be released (e.g., cut through the opening 805 in the
core shaft handle 328) before detaching the baffle 204.
[0112] At block 1162, the release method 1160 includes releasing a
first portion of the atrial-fixation member 202 from the hub
assembly 436 of the hub shaft 316. For example, FIG. 12A
illustrates the implantable device 200 after releasing the
connectors 205 positioned at the posterior side portion P of the
implantable device 200. As described in detail above, the
connectors 205 positioned at the posterior side portion P of the
implantable device 200 can be released by actuating the ring gear
684 of the hub shaft handle 326 to drive the hub assembly 436 to
the second position. With the first set of connectors 205 released,
the first portion of the atrial-fixation member 202 (e.g., the
struts 206 near the posterior side portion P) can further expand
radially outwardly to contact and fixedly engage a wall of the left
atrium LA.
[0113] At block 1163, the release method 1160 includes releasing a
second portion of the atrial-fixation member 202 from the hub
assembly 436 of the hub shaft 316. For example, FIG. 12B
illustrates the implantable device 200 after releasing the
connectors 205 positioned at the anterior side portion A of the
implantable device 200. As described in detail above, the
connectors 205 positioned at the anterior side portion A of the
implantable device 200 can be released by (i) pulling the release
member 685 of the hub shaft handle 326 to disengage the release
shaft 562 from the lock pin 558 and then (ii) actuating the ring
gear 684 of the hub shaft handle 326 to drive the hub assembly 436
to the third position. After release, the second portion of the
atrial-fixation member 202 (e.g., the struts 206 near the anterior
side portion A) can contact and fixedly engage the wall of the left
atrium LA. In some embodiments, the position and/or orientation of
the implantable device 200 can be manipulated after releasing the
first portion of the atrial-fixation member 202 and before
releasing the second portion of the atrial-fixation member 202.
[0114] At block 1164, the release method 1160 includes removing the
delivery system 310 from the patient. For example, the catheters
312-314 can be individually or collectively withdrawn from the
patient such that only the implantable device 200 remains, as shown
in FIG. 12C.
[0115] Referring to FIGS. 2A-12C together, the delivery system 310
has several advantages that enable the delivery system 310 to
reliably implant the implantable device 200 at the mitral valve MV
to have a proper position and orientation. For example, the
delivery system 310 allows for the separate control of the
atrial-fixation member 202 and the coaptation member 204, and
allows these components to be separately released from the delivery
system 310. Additionally, the delivery system 310 facilitates the
longitudinal compression of the implantable device 200 that allows
the implantable device 200 to be navigated through the tight
anatomy of the left atrium LA. Moreover, the hub assembly 436
allows the atrial-fixation member 202 to be released in two stages
to facilitate the proper engagement of the atrial-fixation member
202 with the wall of the left atrium LA. Other advantages are
described in detail throughout.
IV. Selected Additional Embodiments of Hub Assemblies
[0116] FIG. 15 is an enlarged side view of a hub assembly 1536
configured in accordance with additional embodiments of the present
technology. The hub assembly 1536 can (i) include features several
features generally similar or identical to the features of the hub
assembly 436 described in detail above with reference to FIGS.
4-5F, (ii) operate generally similarly or identically to the hub
assembly 436, and/or (iii) can be integrated into the system 310 in
a generally similar or identical manner. For example, with
additional reference to FIGS. 2A and 2B, the hub assembly 1536 is
configured to similarly receive and secure the connectors 205 of
the implantable device 200 and to provide for a controlled,
two-stage release of the atrial-fixation member 202 in which the
struts 206 at the posterior side portion P are released from the
hub assembly 1536 and allowed to expand before the struts 206 at
the anterior side portion A (e.g., as shown in detail in FIGS. 12A
and 12B). For ease, the hub assembly 1536 is described herein with
respect to the features of the implantable device 200 of FIGS. 2A
and 2B, though the hub assembly 1536 can be used to retain and/or
deploy other implantable devices.
[0117] More particularly, the hub assembly 1536 can include an
inner hub component 1540 and an outer hub component 1542 including
a distal opening 1549. The outer hub component 1542 is shown as
partially transparent in FIG. 15 for clarity. The inner hub
component 1540 can include (i) a proximal side or edge 1543a, (ii)
a distal side or edge 1543b, (iii) first recesses 1544 extending
proximally from the distal edge 1543b and configured to receive
corresponding ones of the connectors 205 positioned at the anterior
side portion A of the implantable device 200 (FIGS. 2A and 2B), and
(iv) second recesses 1546 extending proximally from the distal edge
1543b and configured to receive corresponding ones of the
connectors 205 positioned at the posterior side portion P of the
implantable device 200. In FIG. 15, the hub assembly 1536 is
arranged in a first position in which the outer hub component 1542
is positioned to extend over each of the first and second recesses
1544, 1546 such that the first and second recesses 1544, 1556 are
positioned proximal of the distal opening 1549. Thus, when the hub
assembly 1536 is in the first position, the connectors 205 of the
implantable device 200 are secured/restrained in the first and
second recesses 1544, 1546 by the outer hub component 1542.
[0118] The hub assembly 1536 can further include a lead screw 1555
and/or other drive member configured to translate the inner hub
component 1540 relative to the outer hub component 1542, thereby
moving the hub assembly 1536 from the first position to a second
position and from the second position to a third position (e.g.,
via actuation of the hub shaft handle 316 shown in FIGS. 6A-6C). As
described in detail above with reference to FIGS. 4-5F and 12A-12C,
in the second position, at least a portion of each of the second
recesses 1546 can be positioned sufficiently distal of the distal
opening 1549 of the outer hub component 1542 that the connectors
205 positioned at the posterior side portion P of the implantable
device 200 are no longer constrained by the outer hub component
1542, and thus free to disengage from the hub assembly 1536 to
partially deploy the implantable device 200. In the third position,
at least a portion of each of the first recesses 1544 can be
positioned sufficiently distal of the distal opening 1549 that the
connectors 205 positioned at the anterior side portion A of the
implantable device 200 are no longer constrained by the outer hub
component 1542, and thus free to disengage the hub assembly 1536 to
further deploy the implantable device 200. In some embodiments, the
hub assembly 1536 can further include a lock pin 1558 configured to
halt further advancement of the inner hub component 1542 from the
second position to the third position.
[0119] In the illustrated embodiment, the outer hub component 1542
has a distal edge 1503 including a stepped portion 1505 defining a
cut-out region 1507. The outer hub component 1542 can have a
generally cylindrical shape apart from the cut-out region 1507. The
stepped portion 1505 and the cut-out region 1507 can divide the
outer hub component 1542 into a first portion 1504 positioned
and/or aligned over the first recesses 1544 and a second portion
1506 positioned and/or aligned over the second recesses 1546. The
first portion 1504 can have a side length L1 that is longer than a
side length L2 of the second portion 1506. When the inner hub
component 1540 is translated distally relative to the outer hub
component 1542 (e.g., to the second position), the shorter side
length L2 provided by the cut-out region 1507 allows the second
recesses 1546 (and the connectors 205 positioned therein) to extend
out of the distal opening 1549 and become uncovered by the outer
hub component 1542 before the first recesses 1544 (and the
connectors 205 positioned therein). Accordingly, the differential
lengths Li and L2 of the outer hub component 1542 can facilitate
the staged release of the atrial-fixation member 202 while
traversing a shorter overall axial length than a similar hub
assembly with a uniform length. In some aspects of the present
technology, the shorter axial length can help improve steerability
of the hub assembly 1636 in tight anatomies and/or help facilitate
quicker deployment of the implantable device 200, and/or (iii)
enable
[0120] In the illustrated embodiment, the second recesses 1546 have
a length (e.g., extending proximally from the distal edge 1543b
toward the proximal edge 1543a) that is shorter than a length of
the first recesses 1544. As described in detail above with
reference to FIGS. 5A-6C and 12A-12C, this arrangement can further
facilitate the two-stage release of the atrial-fixation member 202.
In some embodiments, the stepped portion 1505 allows a difference
between the lengths of the first and second recesses 1544, 1546 to
be reduced as compared to a difference between the lengths of the
first and second recesses 544, 546 shown in FIGS. 5A-5C, while
still providing the same deployment profile as the hub assembly 536
(e.g., having the same timing and actuation mechanics at the hub
shaft handle 326 shown in FIGS. 6A-6C). In some embodiments, the
first and second recesses 1544, 1546 can have the same or generally
similar sizes and dimensions (e.g., lengths) such that the
two-stage release of the atrial-fixation member 202 is facilitated
only or substantially by the differential lengths Li and L2 of the
outer hub portion 1542.
[0121] FIGS. 16A and 16B are an enlarged side view and a front
isometric view, respectively, of a hub assembly 1636 in accordance
with additional embodiments of the present technology. The hub
assembly 1636 can (i) include features several features generally
similar or identical to the hub assembly 436 and/or the hub
assembly 1536 described in detail above with reference to FIGS.
4-5F and 15, (ii) operate generally similarly or identically to the
hub assembly 436 and/or the hub assembly 1536, and/or (iii) can be
integrated into the system 310 in a generally similar or identical
manner. For example, with additional reference to FIGS. 2A and 2B,
the hub assembly 1636 is configured to similarly receive and secure
the connectors 205 of the implantable device 200 and to provide for
a controlled, multi-stage release of the atrial-fixation member 202
in which the struts 206 at the posterior side portion P are
released from the hub assembly 1536 and allowed to expand before
the struts 206 at the anterior side portion A (e.g., as shown in
detail in FIGS. 12A and 12B). For ease, the hub assembly 1636 is
described herein with respect to the features of the implantable
device 200 of FIGS. 2A and 2B, though the hub assembly 1636 can be
used to retain and/or deploy other implantable devices.
[0122] More particularly, referring to FIGS. 16A and 16B together,
the hub assembly 1636 can include an inner hub component 1640 and
an outer hub component 1642 including a distal opening 1649. The
outer hub component 1642 is shown as partially transparent in FIG.
16A, and the inner hub component 1640 is shown as partially
transparent in FIG. 16B for clarity. The inner hub component 1640
can include (i) a proximal side or edge 1643a, (ii) a distal side
or edge 1643b, (iii) and a plurality of recesses 1610 extending
proximally from the distal edge 1643b and configured to receive
corresponding ones of the connectors 205. In some embodiments, each
of the recesses 1610 can have the same configuration (e.g., size,
shape, dimensions). The outer hub component 1642 can include an
opening 1612 (e.g., an aperture, a slot) that is configured (e.g.,
sized, shaped, dimensioned) to be positioned over a corresponding
one of the recesses 1610 to allow one of the connectors 205 secured
therein to release from within the recess 1610 and disengage the
hub assembly 1636.
[0123] Referring to FIG. 16B, the outer hub component 1642 is
rotatably mounted relative to the inner hub component 1640. For
example, in the illustrated embodiment the hub assembly 1636
further includes a pinion gear 1614, and the outer hub component
1642 includes a ring gear 1616 that is operably coupled to the
pinion gear 1614. In some embodiments, the pinion gear 1614 is
operably coupled to the drive shaft 552 (FIGS. 5D-5F), which
extends from the hub assembly 1636, through the hub shaft 316 (FIG.
4), and to the hub shaft handle 326 (FIGS. 6A-6C). Referring to
FIGS. 6A-6C and 16B together, the hub shaft handle 326 can be
manipulated/actuated by a user to actuate the drive shaft 552 to
drive (e.g., rotate) the pinion gear 1614 to rotate the outer hub
component 1642 relative to the inner hub component 1640 to release
the connectors 205 of the implantable device 200 (FIGS. 2A and 2B)
during device deployment.
[0124] More specifically, referring to FIGS. 2A, 2B, 16A, and 16B
together, the outer hub component 1642 can be rotated to align the
opening 1612 over a corresponding one of the recesses 1610 to
release the connector 205 positioned therein. In operation, the hub
assembly 1636 can initially be positioned as shown in FIG. 16A with
the opening 1612 misaligned with the recesses 1610 such that each
of the connectors 205 is constrained by the outer hub component
1642 in a corresponding one of the recesses 1610. The outer hub
component 1642 can then be rotated to sequentially align the
opening 1612 over individual ones of the recesses 1610 including
the connectors 205 at the posterior side portion P to sequentially
release those ones of the connectors 205, before being further
rotated to sequentially align the opening 1612 over individual ones
of the recesses 1610 including the connectors 205 at the anterior
side portion A to sequentially release those ones of the connectors
205. In this manner, the hub assembly 1636 can provide for the
sequential, multi-stage release of the connectors at the posterior
side portion P and the anterior side portion A of the implantable
device 200.
[0125] In the illustrated embodiment, the opening 1612 is
configured (e.g., shaped and sized) to be sequentially positioned
over individual ones of the recesses 1610 to release the connectors
205 positioned therein. In some aspects of the present technology,
the individual (e.g., one-by-one) release of the connectors 205 can
improve control of the deployment of the atrial-fixation member
202. In other embodiments, the opening 1612 can be sized to be
positioned over two or more of the recesses 1610 at the same time
to, for example, facilitate the simultaneous release of multiple
ones of the connectors 205 secured therein. In some embodiments,
the outer hub component 1642 has two or more openings 1612 spaced
about its circumference such that relative rotation of the inner
and outer hub components 1640, 1642 provides for simultaneous
release of multiple ones of the connectors 205 secured
therebetween.
[0126] In some embodiments, the hub assembly 1636 can have a
relatively shorter length than the hub assemblies 436 and 1536
described in detail above with reference to FIGS. 5A-5F and 15, as
the outer hub component 1642 need not be translated relative to the
inner hub component 1640 to release the connectors 205. In some
aspects of the present technology, reducing the reduced length of
the hub assembly 1636 can help improve steerability of the hub
assembly 1636 in tight anatomies.
V. Further Examples
[0127] The following examples are illustrative of several
embodiments of the present technology:
[0128] 1. A method of implanting a medical device at a cardiac
valve, the method including: [0129] advancing the medical device to
a target position extending across the cardiac valve such that (a)
a first end portion of the medical device is positioned at a first
side of the cardiac valve upstream of a native valve anulus of the
cardiac valve and (b) a second end portion of the medical device is
positioned at a second side of the cardiac valve proximate to
native valve leaflets of the cardiac valve, wherein advancing the
medical device to the target position includes advancing the
medical device while the first end portion of the medical device is
coupled to a first shaft and the second end portion of the medical
device is coupled to a second shaft;
[0130] releasing a first side of the first end portion of the
medical device from the first shaft;
[0131] after releasing the first side of the first end portion of
the medical device, releasing a second side of the first end
portion of the medical device from the first shaft; and
[0132] releasing the second end portion of the medical device from
the second shaft.
[0133] 2. The method of example 1 wherein releasing the first side
of the first end portion of the medical device includes actuating a
handle operably coupled to a proximal end portion of the first
shaft to drive a hub assembly coupled to a distal end portion of
the first shaft to release a plurality of first connectors at the
first side of the first end portion of the medical device.
[0134] 3. The method of example 2 wherein releasing the second side
of the first end portion of the medical device includes further
actuating the handle to drive the hub assembly to release a
plurality of second connectors at the second side of the first end
portion of the medical device.
[0135] 4. The method of any one examples 1-3 wherein the first end
portion of the medical device is coupled to the first shaft via a
hub assembly, wherein the hub assembly includes an inner hub
component that is movable relative to an outer hub component
between a first position, a second position, and a third position,
and wherein-- [0136] advancing the medical device to the target
position includes advancing the medical device while the inner hub
component is in the first position, [0137] releasing the first side
of the first end portion of the medical device includes moving the
inner hub component from the first position to the second position,
and [0138] releasing the second side of the first end portion of
the medical device includes moving the inner hub component from the
second position to the third position.
[0139] 5. The method of any one examples 1-4 wherein the first end
portion of the medical device is coupled to the first shaft via a
hub assembly, wherein the hub assembly includes an inner hub
component that is translatable relative to an outer hub component,
and wherein-- [0140] advancing the medical device to the target
position includes advancing the medical device while the inner hub
component is in a first position relative to the outer hub
component, [0141] releasing the first side of the first end portion
of the medical device includes translating the inner hub component
to a second position relative to the outer hub component, and
[0142] releasing the second side of the first end portion of the
medical device includes translating the inner hub component to a
third position relative to the outer hub component.
[0143] 6. The method of any one examples 1-4 wherein the first end
portion of the medical device is coupled to the first shaft via a
hub assembly, wherein the hub assembly includes an inner hub
component that is rotatable relative to an outer hub component, and
wherein-- [0144] advancing the medical device to the target
position includes advancing the medical device while the inner hub
component is in a first position relative to the outer hub
component, [0145] releasing the first side of the first end portion
of the medical device includes rotating the inner hub component to
a second position relative to the outer hub component, and [0146]
releasing the second side of the first end portion of the medical
device includes rotating the inner hub component to a third
position relative to the outer hub component.
[0147] 7. The method of any one examples 1-6 wherein the first end
portion of the medical device includes a plurality of connectors
coupled to the first shaft via a hub assembly, and wherein-- [0148]
releasing the first side of the first end portion of the medical
device includes sequentially releasing individual first ones of the
connectors, and [0149] releasing the second side of the first end
portion of the medical device includes sequentially releasing
individual second ones of the connectors.
[0150] 8. The method of any one examples 1-6 wherein the first end
portion of the medical device includes a plurality of connectors
coupled to the first shaft via a hub assembly, and wherein-- [0151]
releasing the first side of the first end portion of the medical
device includes simultaneously releasing multiple first ones of the
connectors, and [0152] releasing the second side of the first end
portion of the medical device includes simultaneously releasing
multiple second ones of the connectors.
[0153] 9. The method of any one examples 1-8 wherein the cardiac
valve is a mitral valve, and wherein the method further comprises
capturing a portion of one or more of the native leaflets of the
mitral valve with the medical device.
[0154] 10. The method of any one examples 1-9 wherein the method
includes releasing the second end portion of the medical device
before releasing the first end portion of the medical device.
[0155] 11. The method of any one examples 1-10 wherein the medical
device includes an atrial-fixation member and a coaptation member
extending from the atrial-fixation member, wherein the first end
portion is of the atrial-fixation member, wherein the second end
portion is of the coaptation member, and wherein-- [0156] releasing
the first side of the first end portion of the medical device
includes releasing a posterior side of the atrial-fixation member
that is positioned above the coaptation member; and [0157]
releasing the second side of the first end portion of the medical
device includes releasing an anterior side of the atrial-fixation
member opposite the posterior side.
[0158] 12. A method of implanting a medical device at a cardiac
valve of a heart, the method including: [0159] advancing the
medical device at least partially into a chamber of the heart,
wherein advancing the medical device to the chamber includes
advancing the medical device while a first end portion of the
medical device is coupled to a first shaft and a second end portion
of the medical device is coupled to a second shaft; [0160]
longitudinally compressing the medical device by moving one or both
of the first shaft and the second shaft relative to one another;
[0161] advancing the medical device to a target position extending
across the cardiac valve such that (a) the first end portion of the
medical device is positioned at a first side of the cardiac valve
upstream of a native valve anulus of the cardiac valve and (b) the
second end portion of the medical device is positioned at a second
side of the cardiac valve proximate to native valve leaflets of the
cardiac valve; [0162] releasing the first end portion of the
medical device from the first shaft; and [0163] releasing the
second end portion of the medical device from the second shaft.
[0164] 13. The method of example 12 wherein the cardiac valve is a
mitral valve and the chamber is a left atrium, and wherein
longitudinally compressing the medical device includes
longitudinally compressing the medical device in the left atrium
above the mitral valve.
[0165] 14. The method of example 13 wherein the method further
comprises steering the medical device toward the mitral valve after
longitudinally compressing the medical device.
[0166] 15. A method of implanting a valve repair device at a
cardiac valve, the method comprising: [0167] endovascularly
delivering a distal portion of a delivery catheter to a chamber of
a heart; [0168] unsheathing at least a portion of the valve repair
device from the delivery catheter while in the chamber of the
heart; [0169] longitudinally compressing the valve repair device by
moving one or both of (a) a hub shaft secured to a first end
portion of the valve repair device and (b) a core shaft secured to
a second end portion of the valve repair device relative to one
another; [0170] advancing the valve repair device to a target
position extending across the cardiac valve such that the first end
portion is positioned at a first side of the cardiac valve upstream
of a native valve anulus of the cardiac valve and the second end
portion is positioned at a second side of the cardiac valve
proximate to native valve leaflets of the cardiac valve; [0171]
releasing the second end portion of the valve repair device from
the core shaft; [0172] releasing a first side of the first end
portion of the valve repair device from the hub shaft; and [0173]
after releasing the first side of the first end portion of the
valve repair device, releasing a second side of the first end
portion of the valve repair device from the hub shaft.
[0174] 16. The method of example 15 wherein releasing the first
side of the first end portion of the valve repair device includes
actuating a handle operably coupled to a proximal end portion of
the hub shaft to drive a hub assembly coupled to a distal end
portion of the hub shaft to release a plurality of first connectors
at the first side of the first end portion of the valve repair
device, and wherein releasing the second side of the first end
portion of the valve repair device includes further actuating the
handle to drive the hub assembly to release a plurality of second
connectors at the second side of the first end portion of the valve
repair device.
[0175] 17. The method of example 15 or example 16 wherein the
cardiac valve is a mitral valve and the chamber is a left atrium,
wherein longitudinally compressing the valve repair device includes
longitudinally compressing the valve repair device in a left atrium
above the mitral valve, and wherein the method further comprises
capturing a portion of one or more of the native leaflets of the
mitral valve with the valve repair device.
[0176] 18. The method of any one of examples 15-17 wherein the
valve repair device includes an atrial-fixation member and a
coaptation member extending from the atrial-fixation member,
wherein the first end portion is of the atrial-fixation member,
wherein the second end portion is of the coaptation member, and
wherein-- [0177] releasing the first side of the first end portion
of the valve repair device includes releasing a posterior side of
the atrial-fixation member that is positioned above the coaptation
member; and [0178] releasing the second side of the first end
portion of the valve repair device includes releasing an anterior
side of the atrial-fixation member opposite the posterior side.
[0179] 19. The method of any one of examples 15-18 wherein
releasing the second end portion of the valve repair device from
the core shaft includes actuating a handle operably coupled to the
core shaft to drive the core shaft to disengage a delivery
attachment member fixedly attached to the second end portion of the
valve repair device.
[0180] 20. The method of any one of example 19 wherein the delivery
attachment member is a nut, and wherein actuating the handle to
drive the core shaft to disengage the nut includes rotating a
threaded member of the core shaft to disengage the nut.
VI. Conclusion
[0181] The above detailed description of embodiments of the
technology are not intended to be exhaustive or to limit the
technology to the precise form disclosed above. Although specific
embodiments of, and examples for, the technology are described
above for illustrative purposes, various equivalent modifications
are possible within the scope of the technology as those skilled in
the relevant art will recognize. For example, although steps are
presented in a given order, alternative embodiments can perform
steps in a different order. The various embodiments described
herein can also be combined to provide further embodiments.
[0182] From the foregoing, it will be appreciated that specific
embodiments of the technology have been described herein for
purposes of illustration, but well-known structures and functions
have not been shown or described in detail to avoid unnecessarily
obscuring the description of the embodiments of the technology.
Where the context permits, singular or plural terms can also
include the plural or singular term, respectively.
[0183] Moreover, unless the word "or" is expressly limited to mean
only a single item exclusive from the other items in reference to a
list of two or more items, then the use of "or" in such a list is
to be interpreted as including (a) any single item in the list, (b)
all of the items in the list, or (c) any combination of the items
in the list. Additionally, the term "comprising" is used throughout
to mean including at least the recited feature(s) such that any
greater number of the same feature and/or additional types of other
features are not precluded. It will also be appreciated that
specific embodiments have been described herein for purposes of
illustration, but that various modifications can be made without
deviating from the technology. Further, while advantages associated
with some embodiments of the technology have been described in the
context of those embodiments, other embodiments can also exhibit
such advantages, and not all embodiments need necessarily exhibit
such advantages to fall within the scope of the technology.
Accordingly, the disclosure and associated technology can encompass
other embodiments not expressly shown or described herein.
* * * * *